Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-03-23 @ 6:50 PM
Study NCT ID:
NCT02859558
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early ART to Limit Infection and Establishment of Reservoir
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, 'interventionBrowseModule': {'meshes': [{'id': 'C509700', 'term': 'elvitegravir'}, {'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}, {'id': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.gov@fstrf.org', 'phone': '(301) 628-3348', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.', 'description': 'All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Step 1 Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 48, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Step 1 Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 67, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Step 1 Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 50, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Step 1 Fiebig VI', 'description': 'Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Step1 HIV Negative', 'description': 'Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Step 2 Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody) that enrolled to Step 2.\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Step 2 Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2) that enrolled to Step 2.\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 30, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Step 2 Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band) that enrolled to Step 2.\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 15, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Thalassaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Anogenital dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Gastrointestinal disorder', 'stats': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Escherichia pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Fascial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 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'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Lymphadenitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Monkeypox', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Secondary syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Hepatitis B surface antigen positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Cervical cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Adjustment disorder with depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Substance-induced psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Vascular skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG001', 'title': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG002', 'title': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}], 'classes': [{'title': 'Joint Assay (Integrase + Gag)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.09'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.06'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.07'}]}]}, {'title': 'Integrase Assay', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.24'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.15'}, {'value': '0.10', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.22'}]}]}, {'title': 'Gag Assay', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.13'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.08'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.07'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.44', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 48', 'description': 'Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction \\[qPCR\\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who maintained HIV-1 RNA\\<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA \\>200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA \\<50 copies/mL ), had available CAHD results from week 48 or week 49, and were enrolled during Fiebig Stage I-V.'}, {'type': 'SECONDARY', 'title': 'HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG001', 'title': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG002', 'title': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}], 'classes': [{'title': 'CD4+ T-cell Response to Env', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.09'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'CD4+ T-cell Response to Gag', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.23'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.31'}, {'value': '0.14', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.27'}]}]}, {'title': 'CD4+ T-cell Response to Nef', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.15'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.26'}, {'value': '0.10', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.23'}]}]}, {'title': 'CD4+ T-cell Response to Pol', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.13'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.19'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.056', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.88', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.54', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At week 48', 'description': 'Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.\n\nCytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)', 'unitOfMeasure': 'Percentage of CD4+ T-cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who maintained HIV-1 RNA\\<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA \\>200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA \\<50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.'}, {'type': 'SECONDARY', 'title': 'HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG001', 'title': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG002', 'title': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}], 'classes': [{'title': 'CD8+ T-cell Response to Env', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.08'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.36'}]}]}, {'title': 'CD8+ T-cell Response to Gag', 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.36'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.67'}, {'value': '0.28', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.61'}]}]}, {'title': 'CD8+ T-cell Response to Nef', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.32'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.44'}, {'value': '0.33', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.68'}]}]}, {'title': 'CD8+ T-cell Response to Pol', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.23'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.26'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.12', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.28', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.045', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.085', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.60', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 48 weeks', 'description': 'Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.\n\nCytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)', 'unitOfMeasure': 'Percentage of CD8+ T-cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who maintained HIV-1 RNA\\<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA \\>200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA \\<50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG001', 'title': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'OG002', 'title': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}], 'classes': [{'title': 'Joint Assay (Integrase + Gag)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.07'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.07'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.06'}]}]}, {'title': 'Integrase Assay', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.14'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.09'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.16'}]}]}, {'title': 'Gag Assay', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.07'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.07'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.06'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.69', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.40', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustments for multiple comparisons. P-value based on two-sided test.', 'groupDescription': 'Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 0', 'description': 'Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR \\[qPCR\\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who enrolled during Fiebig Stage I-V and had available CAHD at week 0.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'FG001', 'title': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'FG002', 'title': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'FG003', 'title': 'Fiebig VI', 'description': 'Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'FG004', 'title': 'HIV-negative', 'description': 'Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.'}], 'periods': [{'title': 'Step 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Completed Week 48', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Not Eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did Not Return to Clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal By Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Had to Interrupt antiretroviral (ARV)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-Adherence to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-Adherence to Study Requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Virologic Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Step 2', 'milestones': [{'type': 'STARTED', 'comment': 'Some participants who completed Step 1 did not enroll to Step 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Unexpected Closure of Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from January 2017 to December 2019 at 30 sites in Brazil, Malawi, Peru, Thailand, United States, and Zimbabwe.', 'preAssignmentDetails': 'There was no randomization in this study. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1. Confirmed Fiebig VI and HIV negative participants were replaced.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'BG001', 'title': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'BG002', 'title': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'BG003', 'title': 'Fiebig VI', 'description': 'Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).\n\nelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, {'id': 'BG004', 'title': 'HIV-negative', 'description': 'Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '35'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '40'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '38'}, {'value': '36', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '48'}, {'value': '25', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '39'}, {'value': '27', 'groupId': 'BG005', 'lowerLimit': '23', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-29 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}]}, {'title': '30-39 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}]}, {'title': '40-49 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}]}, {'title': '50+ years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Cisgender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '186', 'groupId': 'BG005'}]}]}, {'title': 'Transgender Spectrum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex at birth.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '126', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '97', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '66', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '133', 'groupId': 'BG005'}]}]}, {'title': 'Malawi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}, {'title': 'Zimbabwe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}, {'title': 'Peru', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'BG000', 'lowerLimit': '20.3', 'upperLimit': '25.6'}, {'value': '25.9', 'groupId': 'BG001', 'lowerLimit': '21.4', 'upperLimit': '28.8'}, {'value': '23.8', 'groupId': 'BG002', 'lowerLimit': '21.4', 'upperLimit': '28.2'}, {'value': '22.7', 'groupId': 'BG003', 'lowerLimit': '17.7', 'upperLimit': '28.4'}, {'value': '23.2', 'groupId': 'BG004', 'lowerLimit': '19.4', 'upperLimit': '26.1'}, {'value': '24.0', 'groupId': 'BG005', 'lowerLimit': '21.2', 'upperLimit': '28.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV-1 RNA (log10 copies per mL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'BG000', 'lowerLimit': '5.3', 'upperLimit': '7.0'}, {'value': '6.5', 'groupId': 'BG001', 'lowerLimit': '6.0', 'upperLimit': '7.0'}, {'value': '5.4', 'groupId': 'BG002', 'lowerLimit': '5.0', 'upperLimit': '6.4'}, {'value': '5.0', 'groupId': 'BG003', 'lowerLimit': '3.0', 'upperLimit': '6.3'}, {'value': '1.6', 'groupId': 'BG004', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '6.2', 'groupId': 'BG005', 'lowerLimit': '5.2', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'RNA levels below the lower limit of quantification (40 copies per mL) were imputed as 39 copies per mL.', 'unitOfMeasure': 'log10(copies per mL)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV-1 RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'title': '<40 copies per mL', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': '40 - <1000 copies per mL', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': '1000 - <10,000 copies per mL', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': '10,000 - <100,000 copies per mL', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': '100,000 - <1,000,000 copies per mL', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}, {'title': '1,000,000 - <10,000,000 copies per mL', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}, {'title': '>= 10,000,000 copies per mL', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '192', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '348', 'groupId': 'BG000', 'lowerLimit': '211', 'upperLimit': '493'}, {'value': '383', 'groupId': 'BG001', 'lowerLimit': '264', 'upperLimit': '538'}, {'value': '490', 'groupId': 'BG002', 'lowerLimit': '366', 'upperLimit': '652'}, {'value': '436', 'groupId': 'BG003', 'lowerLimit': '401', 'upperLimit': '647'}, {'value': '1090', 'groupId': 'BG004', 'lowerLimit': '604', 'upperLimit': '1576'}, {'value': '406', 'groupId': 'BG005', 'lowerLimit': '284', 'upperLimit': '575'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells per mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Baseline CD4 measurements were not obtained for three participants.'}, {'title': 'CD8 Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '188', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'BG000', 'lowerLimit': '176', 'upperLimit': '463'}, {'value': '544', 'groupId': 'BG001', 'lowerLimit': '309', 'upperLimit': '923'}, {'value': '1016', 'groupId': 'BG002', 'lowerLimit': '766', 'upperLimit': '1777'}, {'value': '1401', 'groupId': 'BG003', 'lowerLimit': '932', 'upperLimit': '1843'}, {'value': '474', 'groupId': 'BG004', 'lowerLimit': '372', 'upperLimit': '575'}, {'value': '613', 'groupId': 'BG005', 'lowerLimit': '336', 'upperLimit': '1030'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells per mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Baseline CD8 measurements were not obtained for seven participants.'}, {'title': 'Cell-associated HIV-1 DNA', 'classes': [{'title': 'Integrase Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7739', 'groupId': 'BG000', 'lowerLimit': '219', 'upperLimit': '28351'}, {'value': '15440', 'groupId': 'BG001', 'lowerLimit': '3716', 'upperLimit': '34658'}, {'value': '10104', 'groupId': 'BG002', 'lowerLimit': '1333', 'upperLimit': '29716'}, {'value': '4575', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '9533'}, {'value': '0', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '10507', 'groupId': 'BG005', 'lowerLimit': '1759', 'upperLimit': '29499'}]}]}, {'title': 'Gag Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4455', 'groupId': 'BG000', 'lowerLimit': '1183', 'upperLimit': '11782'}, {'value': '6357', 'groupId': 'BG001', 'lowerLimit': '2794', 'upperLimit': '17213'}, {'value': '5388', 'groupId': 'BG002', 'lowerLimit': '2270', 'upperLimit': '12938'}, {'value': '3990', 'groupId': 'BG003', 'lowerLimit': '1998', 'upperLimit': '11000'}, {'value': '0', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '5586', 'groupId': 'BG005', 'lowerLimit': '2219', 'upperLimit': '13699'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'copies per 5 million CD4+ T-cells', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'All participants with available baseline measurements.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-17', 'size': 1982966, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-02T15:00', 'hasProtocol': True}, {'date': '2021-09-14', 'size': 494228, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-05T15:09', 'hasProtocol': False}, {'date': '2016-06-09', 'size': 634998, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-22T09:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2016-08-04', 'resultsFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-12-02', 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)', 'timeFrame': 'At week 48', 'description': 'Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction \\[qPCR\\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.'}], 'secondaryOutcomes': [{'measure': 'HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry', 'timeFrame': 'At week 48', 'description': 'Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.\n\nCytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)'}, {'measure': 'HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry', 'timeFrame': 'At 48 weeks', 'description': 'Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.\n\nCytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)'}, {'measure': 'Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation', 'timeFrame': 'At week 0', 'description': 'Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR \\[qPCR\\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '33382405', 'type': 'DERIVED', 'citation': 'Crowell TA, Ritz J, Coombs RW, Zheng L, Eron JJ, Mellors JW, Dragavon J, van Zyl GU, Lama JR, Ruxrungtham K, Grinsztejn B, Arduino RC, Fox L, Ananworanich J, Daar ES; AIDS Clinical Trials Group A5354/EARLIER (Early ART to Limit Infection and Establishment of Reservoir) Study Team. Novel Criteria for Diagnosing Acute and Early Human Immunodeficiency Virus Infection in a Multinational Study of Early Antiretroviral Therapy Initiation. Clin Infect Dis. 2021 Aug 2;73(3):e643-e651. doi: 10.1093/cid/ciaa1893.'}], 'seeAlsoLinks': [{'url': 'http://rsc.tech-res.com/clinical-research-sites/safety-reporting/daids-grading-tables', 'label': 'The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.1, July 2017'}, {'url': 'http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids', 'label': 'Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010'}]}, 'descriptionModule': {'briefSummary': 'The study was done to:\n\n* Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1\n* See how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection\n* Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART\n* See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood', 'detailedDescription': 'This was a Phase II, prospective, open-label two-step study to measure the effects of early ART on the establishment of HIV-1 reservoir and HIV-1-specific immunity. Participants were enrolled if they fulfilled the inclusion criteria for acute HIV-1 infection (AHI) diagnosis within 7 days prior to entry and had an enrollment visit with the immediate initiation of ART. Plasma and serum samples for Fiebig staging were collected at the time of ART initiation.\n\nParticipants were followed for up to 216 weeks (72 weeks on Step 1 and 144 weeks on Step 2). Evaluations at weeks 2 and 8 on Step 1 were performed via telephone.\n\nThe Fiebig stage-classification system was used to characterize the progression from HIV-1 exposure to HIV-1 seroconversion at the time of ART initiation. In this study, the five Fiebig stages of interest were simplified into three study groups as described below (based on HIV-1 antibody diagnostic profile at time of ART initiation).\n\nThe primary analysis was based on Step 1. Step 2 was added to the study for long term follow-up. The rationale for the extended follow-up period was to expand the number of available participants for future therapeutic and cure studies without the burden of frequent visits and the cost of study-provided laboratory testing.\n\nGroup 1: Fiebig I/II (non-reactive HIV-1 antibody)\n\nGroup 2: Fiebig III/IV (reactive HIV-1 antibody and negative or indeterminate results on the Western Blot (WB) or Geenius HIV-1/HIV-2)\n\nGroup 3: Fiebig V (reactive HIV-1 antibody and positive WB or Geenius HIV-1/HIV-2 without p31 band)\n\nAlthough participants in Fiebig VI (positive WB or Geenius HIV-1/HIV-2 with p31 band) were not specifically targeted for enrollment in this study, it was possible that a small number of participants would be determined to be in Fiebig VI (positive Western blot or Geenius HIV-1/HIV-2 with p31 band) based on analysis of the entry samples. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1, allowing ample time for them to pursue alternative sources for ART. Enrolled participants without HIV or in Fiebig VI were replaced.\n\nThe study-provided regimen was single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Other non-study-provided antiretroviral (ARV) regimens were also allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAppropriate documentation from medical records of diagnosis of acute HIV-1 infection (AHI) within 7 days prior to enrollment, that includes one of the following:\n\n1. A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1 antibody within 7 days prior to entry OR\n2. A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study entry AND a negative/indeterminate WB or negative/indeterminate Geenius HIV-1/HIV-2 Supplemental Assay within 7 days prior to entry OR\n3. A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to study entry AND a documented reactive HIV-1 antibody or positive WB that is negative for p31 band or a positive Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band within 7 days prior to entry OR\n4. ARCHITECT or GSCOMBO S/CO ≥10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry OR\n5. ARCHITECT or GSCOMBO S/CO ≥1 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND a known prior S/CO \\<0.5 within 90 days prior to entry OR\n6. ARCHITECT or GSCOMBO S/CO \\>0.5 but \\<10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days prior to entry\n\nNote A: HIV-1 RNA result must be reported from an FDA-approved or CE-marked assay.\n\nNote B: Since characterization of Fiebig stage using samples at the time of ART initiation was performed with results known within 12 weeks based on standardized, centralized testing, an estimated Fiebig group at enrollment based on inclusion criteria as shown in the table above will provide additional real-time monitoring for accruals into each study group.\n\n* Ability and willingness of candidate to provide written informed consent.\n* Ability and willingness to initiate ART at enrollment.\n* Ability and willingness to participate in scheduled study visits for up to 72 weeks.\n* Female candidates of reproductive potential who are not pregnant at the time of enrollment and who will receive the study-provided EVG/COBI/FTC/TAF and must agree not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female candidate must agree to use at least one reliable form of contraceptive while receiving study-provided treatment.\n\nFemale candidates are considered to be of reproductive potential if any of the following conditions apply:\n\n* Candidate has experienced menarche.\n* Candidate has not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.\n* Candidate has not experienced menopause, defined as lack of menstruation within the preceding 12 months.\n\nAcceptable contraceptive methods include:\n\n* Condoms (male or female) with or without a spermicidal agent\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device\n* Hormonal contraceptive\n\nFemale candidates who are not of reproductive potential or whose male partner(s) has documented azoospermia are not required to use contraceptives. Any statement of self-reported sterility or that of her partner must be entered in the source documents.\n\nNOTE: Acceptable documentation of lack of reproductive potential is oral or written documentation from the individual.\n\nFemale candidates who are prescribed a non-study-provided ARV regimen should discuss the safety of that regimen during conception and pregnancy with the prescribing physician. Such individuals should follow medical guidance regarding any potential need for contraception while using the non-study-provided ARV regimen.\n\nNote: Pregnant and breastfeeding women may enroll in the study provided that they meet the eligibility requirements and have access to non-study-provided ARV regimens.\n\nExclusion Criteria:\n\n* Positive HIV-1 antibody test ≥90 days prior to study entry.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.\n* Receipt of an investigational study agent within 28 days prior to enrollment\n* Chronic or recurrent use of medications that modify host immune response, eg, oral or parenteral steroids, cancer chemotherapy.\n* AHI diagnosis within 60 days after receiving any investigational ARV or HIV-1 vaccine or immune prophylaxis for HIV-1 infection.\n* Use of ARVs for pre- or post-exposure prophylaxis within 60 days prior to the diagnosis of AHI.'}, 'identificationModule': {'nctId': 'NCT02859558', 'acronym': 'EARLIER', 'briefTitle': 'Early ART to Limit Infection and Establishment of Reservoir', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses', 'orgStudyIdInfo': {'id': 'ACTG A5354'}, 'secondaryIdInfos': [{'id': '2UM1AI068636', 'link': 'https://reporter.nih.gov/quickSearch/2UM1AI068636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Fiebig I/II', 'description': 'Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).', 'interventionNames': ['Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Fiebig III/IV', 'description': 'Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).', 'interventionNames': ['Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Fiebig V', 'description': 'Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).', 'interventionNames': ['Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy']}], 'interventions': [{'name': 'elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy', 'type': 'DRUG', 'otherNames': ['Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya', 'Single-tablet regimen BIC/FTC/TAF or Biktarvy'], 'description': 'Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.', 'armGroupLabels': ['Arm 1: Fiebig I/II', 'Arm 2: Fiebig III/IV', 'Arm 3: Fiebig V']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': '31788 Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ucsd, Avrc Crs (701)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Med. Ctr. CRS (603)', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman Walker Health CRS (31791)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Ponce de Leon Center CRS (5802)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS (2701)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Univ. Med. Ctr. ACTG CRS (2702)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital ACTG CRS (101)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hosp. ACTG CRS (107)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University CRS (2101)', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': '31786 New Jersey Medical School Clinical Research Center CRS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '7804 Weill Cornell Chelsea CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Physicians and Surgeons CRS (30329)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': '3201 Chapel Hill CRS', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Greensboro CRS (3203)', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ. of Cincinnati CRS (2401)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univ. AIDS CRS (2301)', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '6201 Penn Therapeutics CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pittsburgh CRS (1001)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hosp. ACTG CRS (2951)', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': '31443 Trinity Health and Wellness Center CRS', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '31473 Houston AIDS Research Team (HART) CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington AIDS CRS (1401)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '9043010', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora da Conceicao CRS (12201)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '21045', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Pesquisa Clinica Evandro Chagas (12101)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Malawi CRS (12001)', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'city': 'San Isidro', 'state': 'Lima region', 'country': 'Peru', 'facility': 'San Miguel CRS (11302)', 'geoPoint': {'lat': -12.09655, 'lon': -77.04258}}, {'zip': '18', 'city': 'Lima', 'country': 'Peru', 'facility': 'Barranco CRS', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '10330', 'city': 'Bangkok', 'state': 'Patumwan', 'country': 'Thailand', 'facility': '31802 Thai Red Cross AIDS Research Center Treatment (TRC-ARC Treatment) CRS', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Milton Park CRS (30313)', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally (ACTG) by NIH.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie results in the publication, after deidentification.', 'accessCriteria': '* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.\n* For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.\n* By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}