Viewing Study NCT00663234

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Ignite Creation Date: 2025-12-25 @ 2:36 AM
Ignite Modification Date: 2026-01-06 @ 4:10 AM
Study NCT ID: NCT00663234
Status: TERMINATED
Last Update Posted: 2016-04-06
First Post: 2008-04-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mallen@fhi360.org', 'phone': '(919) 405-1429', 'title': 'Melissa Allen, Director, IMPAACT Operations Center', 'organization': 'Family Health International (FHI 360)'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trial 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}, 'limitationsAndCaveats': {'description': 'Target enrollment was 40 participants (20 in each age cohort). However, the study was prematurely discontinued due to administrative reasons, having enrolled only 28 participants (21 participants aged 10 to 14 and 7 participants aged 15 to 23).'}}, 'adverseEventsModule': {'timeFrame': 'From date of Atorvastatin initiation until Week 48.', 'description': 'The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.', 'eventGroups': [{'id': 'EG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.', 'otherNumAtRisk': 28, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngeal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '15.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '15.9'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '20.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '38.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '38.0'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '45.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '43.5', 'upperLimit': '76.2'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '63.4'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '73.1'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '36.6', 'upperLimit': '69.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 4 (N=27)', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '78.3'}]}]}, {'title': 'Week 12 (N=27)', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '65.3'}]}]}, {'title': 'Week 24 (N=26)', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '77.4'}]}]}, {'title': 'Week 48 (N=26)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '74.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '88.7'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '88.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '97.2'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '77.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '74.2'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '67.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '74.2'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '36.2', 'upperLimit': '70.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 to 14 Years Old', 'description': 'Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen\n\nAtorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}, {'id': 'OG001', 'title': '15 to 23 Years Old', 'description': 'Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen\n\nAtorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '94.7'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '75.5'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '65.9'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '71.4'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '94.7'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '71.4'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '94.7'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '67.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NNRTI-exposed', 'description': 'Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.'}, {'id': 'OG001', 'title': 'NNRTI-unexposed', 'description': 'Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '34.5', 'upperLimit': '90.2'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '36.8', 'upperLimit': '77.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '83.1'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '63.2'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '74.9'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '41.8', 'upperLimit': '81.3'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '83.1'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '72.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.'}, {'type': 'PRIMARY', 'title': 'Percent Change in LDL Cholesterol (LDL-C) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in LDL-C at Week 4 (N=27)', 'categories': [{'measurements': [{'value': '-30.3', 'groupId': 'OG000', 'lowerLimit': '-34.6', 'upperLimit': '-26.1'}]}]}, {'title': 'Percent change in LDL-C at Week 12 (N=27)', 'categories': [{'measurements': [{'value': '-26.5', 'groupId': 'OG000', 'lowerLimit': '-32.4', 'upperLimit': '-20.5'}]}]}, {'title': 'Percent change in LDL-C at Week 24 (N=26)', 'categories': [{'measurements': [{'value': '-28.0', 'groupId': 'OG000', 'lowerLimit': '-32.7', 'upperLimit': '-23.4'}]}]}, {'title': 'Percent change in LDL-C at Week 48 (N=26)', 'categories': [{'measurements': [{'value': '-26.4', 'groupId': 'OG000', 'lowerLimit': '-33.1', 'upperLimit': '-19.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'unitOfMeasure': 'percentage of LDL-C at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Fasting Total Cholesterol (TC) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in TC at Week 4 (N=27)', 'categories': [{'measurements': [{'value': '-23.8', 'groupId': 'OG000', 'lowerLimit': '-26.8', 'upperLimit': '-20.8'}]}]}, {'title': 'Percent change in TC at Week 12 (N=27)', 'categories': [{'measurements': [{'value': '-21.1', 'groupId': 'OG000', 'lowerLimit': '-25.1', 'upperLimit': '-17.1'}]}]}, {'title': 'Percent change in TC at Week 24 (N=26)', 'categories': [{'measurements': [{'value': '-22.5', 'groupId': 'OG000', 'lowerLimit': '-26.0', 'upperLimit': '-19.0'}]}]}, {'title': 'Percent change in TC at Week 48 (N=26)', 'categories': [{'measurements': [{'value': '-21.5', 'groupId': 'OG000', 'lowerLimit': '-26.4', 'upperLimit': '-16.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'unitOfMeasure': 'percentage of TC at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Triglycerides (TG) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in TG at Week 4 (N=27)', 'categories': [{'measurements': [{'value': '-9.5', 'groupId': 'OG000', 'lowerLimit': '-20.4', 'upperLimit': '1.4'}]}]}, {'title': 'Percent change in TG at Week 12 (N=27)', 'categories': [{'measurements': [{'value': '-12.6', 'groupId': 'OG000', 'lowerLimit': '-19.5', 'upperLimit': '-5.7'}]}]}, {'title': 'Percent change in TG at Week 24 (N=26)', 'categories': [{'measurements': [{'value': '-11.3', 'groupId': 'OG000', 'lowerLimit': '-22.8', 'upperLimit': '0.2'}]}]}, {'title': 'Percent change in TG at Week 48 (N=26)', 'categories': [{'measurements': [{'value': '-12.6', 'groupId': 'OG000', 'lowerLimit': '-22.5', 'upperLimit': '-2.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'unitOfMeasure': 'percentage of TG at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in HDL-cholesterol (HDL-C) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in HDL-C at Week 4 (N=27)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '6.1'}]}]}, {'title': 'Percent change in HDL-C at Week 12 (N=27)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '5.7'}]}]}, {'title': 'Percent change in HDL-C at Week 24 (N=26)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '9.1'}]}]}, {'title': 'Percent change in HDL-C at Week 48 (N=26)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '11.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'unitOfMeasure': 'percentage of HDL-C at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in Apo A-1 at Week 12 (N=24)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '4.8'}]}]}, {'title': 'Percent change in Apo A-1 at Week 24 (N=23)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '7.5'}]}]}, {'title': 'Percent change in Apo A-1 at Week 48 (N=24)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study entry and weeks 12, 24, and 48', 'unitOfMeasure': 'percentage of Apo A-1 at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Apolipoprotein B (Apo B) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in Apo B at Week 12 (N=24)', 'categories': [{'measurements': [{'value': '-27.2', 'groupId': 'OG000', 'lowerLimit': '-32.0', 'upperLimit': '-22.4'}]}]}, {'title': 'Percent change in Apo B at Week 24 (N=23)', 'categories': [{'measurements': [{'value': '-25.1', 'groupId': 'OG000', 'lowerLimit': '-29.5', 'upperLimit': '-20.7'}]}]}, {'title': 'Percent change in Apo B at Week 48 (N=24)', 'categories': [{'measurements': [{'value': '-23.8', 'groupId': 'OG000', 'lowerLimit': '-30.5', 'upperLimit': '-17.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study entry and weeks 12, 24, and 48', 'unitOfMeasure': 'percentage of Apo B at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in hs-CRP at Week 12 (N=25)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '44'}]}]}, {'title': 'Percent change in hs-CRP at Week 24 (N=23)', 'categories': [{'measurements': [{'value': '-20', 'groupId': 'OG000', 'lowerLimit': '-67', 'upperLimit': '0'}]}]}, {'title': 'Percent change in hs-CRP at Week 48 (N=24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-78', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Study entry and weeks 12, 24, and 48', 'unitOfMeasure': 'percentage of hs-CRP at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Interleukin 6 (IL-6) From Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Percent change in IL-6 at Week 12 (N=24)', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-32', 'upperLimit': '110'}]}]}, {'title': 'Percent change in IL-6 at Week 24 (N=23)', 'categories': [{'measurements': [{'value': '-19', 'groupId': 'OG000', 'lowerLimit': '-32', 'upperLimit': '-5'}]}]}, {'title': 'Percent change in IL-6 at Week 48 (N=24)', 'categories': [{'measurements': [{'value': '-11.5', 'groupId': 'OG000', 'lowerLimit': '-34', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Study entry and weeks 12, 24, and 48', 'unitOfMeasure': 'percentage of IL-6 at study entry', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Undetectable Plasma HIV-1 RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 0 (N=28)', 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '85.0'}]}]}, {'title': 'Week 12 (N=26)', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '84.0'}]}]}, {'title': 'Week 24 (N=26)', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '77.0'}]}]}, {'title': 'Week 48 (N=26)', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '84.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry and weeks 12, 24, and 48', 'description': 'Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 to 14 Years Old', 'description': 'Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen\n\nAtorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}, {'id': 'OG001', 'title': '15 to 23 Years Old', 'description': 'Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen\n\nAtorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '52.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '52.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.3'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '65.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 to 14 Years Old', 'description': 'Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen\n\nAtorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}, {'id': 'OG001', 'title': '15 to 23 Years Old', 'description': 'Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen\n\nAtorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '52.1'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '43.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '52.1'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '43.7'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '65.9'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '48.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated Atorvastatin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Dose Increased to 20 mg at Week 8', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Not willing to adhere to requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Atorvastatin', 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '10 - <15 years old', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '15 - <19 years old', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '19 - <24 years old', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Black Non-Hispanic', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic (Regardless of Race)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Asian, Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Percent at screening, Categorical', 'classes': [{'title': '15% to <25%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '>=25%', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA, Categorical', 'classes': [{'title': '>=Lower limit of quantification of assay', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': '<Lower limit of quantification of assay', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Antiretroviral (ARV) Regimen at entry, Categorical', 'classes': [{'title': 'At least one PI and at least one NNRTI', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'At least one PI and no NNRTI', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'At least one NNRTI and no PI', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other ARV regimen', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'ARV regimens are categorized based on whether or not they contain Protease Inhibitors (PIs) and/or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs).', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who initiated Atorvastatin were included in the baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'The study was prematurely discontinued due to administrative reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2008-04-21', 'resultsFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-08', 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.'}, {'measure': 'Percentage of Participants Experiencing at Least One Adverse Event (AE)', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.'}, {'measure': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.'}, {'measure': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.'}, {'measure': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.'}, {'measure': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.'}, {'measure': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.'}, {'measure': 'Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48', 'description': 'Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.'}, {'measure': 'Percent Change in LDL Cholesterol (LDL-C) From Study Entry', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48'}, {'measure': 'Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.'}, {'measure': 'Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group', 'timeFrame': 'Study entry to weeks 12, 24, and 48', 'description': 'AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Fasting Total Cholesterol (TC) From Study Entry', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48'}, {'measure': 'Percent Change in Triglycerides (TG) From Study Entry', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48'}, {'measure': 'Percent Change in HDL-cholesterol (HDL-C) From Study Entry', 'timeFrame': 'Study entry and weeks 4, 12, 24, and 48'}, {'measure': 'Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry', 'timeFrame': 'Study entry and weeks 12, 24, and 48'}, {'measure': 'Percent Change in Apolipoprotein B (Apo B) From Study Entry', 'timeFrame': 'Study entry and weeks 12, 24, and 48'}, {'measure': 'Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry', 'timeFrame': 'Study entry and weeks 12, 24, and 48'}, {'measure': 'Percent Change in Interleukin 6 (IL-6) From Study Entry', 'timeFrame': 'Study entry and weeks 12, 24, and 48'}, {'measure': 'Percentage of Participants With Undetectable Plasma HIV-1 RNA', 'timeFrame': 'Study entry and weeks 12, 24, and 48', 'description': 'Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections', 'Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '15030304', 'type': 'BACKGROUND', 'citation': 'Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. doi: 10.1586/14779072.1.1.143.'}, {'pmid': '14727985', 'type': 'BACKGROUND', 'citation': 'Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. doi: 10.2165/00129784-200202020-00003.'}, {'pmid': '16314198', 'type': 'BACKGROUND', 'citation': 'Solorzano Santos F, Gochicoa Rangel LG, Palacios Saucedo G, Vazquez Rosales G, Miranda Novales MG. Hypertriglyceridemia and hypercholesterolemia in human immunodeficiency virus-1-infected children treated with protease inhibitors. Arch Med Res. 2006 Jan;37(1):129-32. doi: 10.1016/j.arcmed.2005.05.013.'}, {'type': 'BACKGROUND', 'citation': 'The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)'}]}, 'descriptionModule': {'briefSummary': 'Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.', 'detailedDescription': 'Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein cholesterol (LDL-C) levels, in HIV-infected children receiving stable antiretroviral therapy.\n\nParticipants were assigned to one of two groups based on age (10 to 14 years or 15 to 23 years) and were treated for a maximum of 48 weeks. The first six participants enrolled in the study were in the 15 to 23 year old age group. Once safety data through week 8 on these 6 participants was analyzed, the remaining participants were enrolled. All participants received atorvastatin in combination with a stable antiretroviral regimen. Each participant was followed independently according to a dose escalation algorithm for atorvastatin. Participants began dosing at 10 mg daily. If efficacy criteria were not met, dosing increased to 20 mg daily at week 8. Since dose escalations were done within subject, safety and efficacy rates were presented for the dose-escalation strategy overall and not for individual doses. Atorvastatin was provided by the study, but antiretrovirals were not.\n\nStudy visits occurred at study entry and weeks 4, 8, 12, 24, 36, and 48. Safety labs were collected at all study visits. Blood collection for lipid measurements occurred at weeks 4, 12, 24 and 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of HIV-1 infection\n* CD4 % of at least 15 at screening\n* HIV-1 viral load of less than 10,000 copies/ml at screening\n* On a stable antiretroviral therapy regimen for at least 6 months\n* Tanner stage of 2 or higher\n* At least two LDL-C measurements of 130 mg/dL or higher over the 6 months prior to screening and after documented attempts at modifying diet and other risk factors. More information on this criterion can be found in the protocol.\n* Able to fast overnight for 8 hours\n* Negative pregnancy test at screening\n* Agree to use two appropriate forms of contraception (female participants). More information on this criterion can be found in the protocol.\n\nExclusion Criteria:\n\n* Certain abnormal laboratory values\n* Any laboratory or unresolved clinical toxicity of Grade 3 or higher\n* Unlikely to remain on current antiretroviral therapy for at least six months after study entry\n* Use of statin, fibrate, or niacin within 3 months prior to study entry\n* Evidence of chronic ongoing myositis or history of myopathy or neuromuscular disorder\n* Symptomatic peripheral neuropathy within 6 months prior to study entry\n* Pharmacologic treatment for depression or other mental disorder excluding Attention Deficit Disorder within 30 days prior to study entry\n* Presence of an active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy within 2 weeks prior to screening.\n* Chemotherapy for malignancy within 3 months prior to study entry\n* Hepatitis B Surface Antigen positive\n* Hepatitis C viremia\n* Insulin-dependent diabetes mellitus\n* Required treatment with an agent contraindicated with either atorvastatin or PIs. More information on this criterion can be found in the protocol.\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00663234', 'briefTitle': 'IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia', 'organization': {'class': 'NETWORK', 'fullName': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group'}, 'officialTitle': 'Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children and Adolescents', 'orgStudyIdInfo': {'id': 'IMPAACT P1063'}, 'secondaryIdInfos': [{'id': 'U01AI068632', 'link': 'https://reporter.nih.gov/quickSearch/U01AI068632', 'type': 'NIH'}, {'id': '10167'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Age 10 to 14', 'description': 'Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Age 15 to 23', 'description': 'Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': '10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.', 'armGroupLabels': ['Age 10 to 14', 'Age 15 to 23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ. of Colorado Denver NICHD CRS (5052)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Tampa (5018)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Chicago Children's CRS (4001)", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University (5095)', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center Ped. HIV Program NICHD CRS (5011)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University NY (5012)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Metropolitan Hospital (5003)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx-Lebanon Hospital IMPAACT CRS (6901)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Jude/UTHSC CRS (6501)', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hosp. CRS (3801)", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ann Melvin, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Seattle Children's Hospital"}, {'name': 'Marilyn Crain, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}