Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-10 @ 1:40 PM
Study NCT ID:
NCT02470650
Status:
WITHDRAWN
Last Update Posted:
2025-07-30
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509700', 'term': 'elvitegravir'}, {'id': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'C492871', 'term': 'abacavir, lamivudine drug combination'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D000068696', 'term': 'Rilpivirine'}], '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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D009570', 'term': 'Nitriles'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-04', 'size': 1938186, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-25T07:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of mortality and clinical progression', 'timeFrame': '48 weeks', 'description': 'Defined by diagnostic AIDS diseases or death'}], 'primaryOutcomes': [{'measure': 'efficiency (cost-effectiveness)', 'timeFrame': '48 weeks of initiation antiretroviral treatment', 'description': 'Antiretroviral treatment effectiveness defined by the number of patients with \\<37 copies/ml viral load at the 48 weeks and the treatment cost defined by the sum of cost ogfthe antiretroviral treatment and all its consequences (adverse effects, changes of pattern study antiretroviral resistance in case of being necessary, days of sick leave by the patient and hospital admission days) that occur in the 48 weeks. The price of the antiretroviral treatment will be defined by Spanish official price.'}], 'secondaryOutcomes': [{'measure': 'Change in the number of CD4 cells', 'timeFrame': '48 weeks', 'description': 'Change in the number of CD4 cells at 48 weeks'}, {'measure': 'number of patients with virologic response ratio copies mL plasma viral load)', 'timeFrame': '48 weeks', 'description': 'less than 37 copies/mL in plasma viral load'}, {'measure': 'Change in body composition and mineral density bone lumbar) measurement with DEXA', 'timeFrame': '48 weeks', 'description': 'Measurement baseline and at 48 weeks. DEXA Scan (Dual X-ray Absorptiometry) to Measure Bone Health'}, {'measure': 'Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function', 'timeFrame': '48 weeks', 'description': 'Defined by creatinine clearance, glomerular filtration rate - eGFR - and renal tubular function at week 48 filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['comparative effectiveness'], 'conditions': ['Patient Compliance', 'Antiretroviral Therapy Intolerance']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.', 'detailedDescription': 'Secondary objectives:\n\n* patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)\n* Change in the number of CD4 cells at 48 weeks\n* Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks\n* Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks\n* Rate of mortality and clinical progression at 48 weeks\n* general tolerability and safety: adverse events (AA) and serious AA description'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-negative pregnancy test in women of childbearing age\n* 2- stable HIV-1 infection clinically and not take antiretroviral therapy\n* 3- viral load HIV \\<100,000 copies\n* 4- CD4 cells \\>100 cels/mm3\n* 5- Glomerular filtration \\>70mlmin\n* 6- have a negative HLA B5701\n* 7-.patients should have given informed written consent\n* 8- in the opinion of the investigator, be able to follow the design of the Protocol visits\n\nExclusion Criteria:\n\n* 1-. Patients who had virologic failure with any antiretroviral therapy\n* 2- evidence of prior mutations of the study drugs\n* 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study\n* 4- contraindication to the drugs study\n* 5- any condition that does not allow to ensure the correct compliance to the study\n* 6- uncontrolled previous psychiatric illness\n* 7- Current or active addiction or alcoholism'}, 'identificationModule': {'nctId': 'NCT02470650', 'briefTitle': 'Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks', 'orgStudyIdInfo': {'id': 'Cost-Effect-Clinic'}, 'secondaryIdInfos': [{'id': '2014-004820-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'elvitegravir/cobicistat/emtricitabine/tenofovir', 'description': 'EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day)', 'interventionNames': ['Drug: elvitegravir/cobicistat/emtricitabine/tenofovir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'darunavir+ritonavir+lamivudine', 'description': 'Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day', 'interventionNames': ['Drug: Darunavir', 'Drug: Ritonavir', 'Drug: Lamivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'abacavir/lamivudine+rilpivirine', 'description': 'Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day', 'interventionNames': ['Drug: abacavir/lamivudine', 'Drug: rilpivirine']}], 'interventions': [{'name': 'elvitegravir/cobicistat/emtricitabine/tenofovir', 'type': 'DRUG', 'otherNames': ['Stribild'], 'description': '1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s)', 'armGroupLabels': ['elvitegravir/cobicistat/emtricitabine/tenofovir']}, {'name': 'Darunavir', 'type': 'DRUG', 'otherNames': ['prezista'], 'description': 'Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day', 'armGroupLabels': ['darunavir+ritonavir+lamivudine']}, {'name': 'abacavir/lamivudine', 'type': 'DRUG', 'otherNames': ['Kivexa'], 'description': 'Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day', 'armGroupLabels': ['abacavir/lamivudine+rilpivirine']}, {'name': 'Ritonavir', 'type': 'DRUG', 'otherNames': ['Norvir'], 'description': 'Ritonavir 100 mg recovered tablet once a day', 'armGroupLabels': ['darunavir+ritonavir+lamivudine']}, {'name': 'Lamivudine', 'type': 'DRUG', 'otherNames': ['Epivir'], 'description': 'lamivudine 300mg (Epivir) 1 recovered tablet', 'armGroupLabels': ['darunavir+ritonavir+lamivudine']}, {'name': 'rilpivirine', 'type': 'DRUG', 'otherNames': ['Edurant'], 'description': 'rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day', 'armGroupLabels': ['abacavir/lamivudine+rilpivirine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mallolas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juan A. Arnaiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Josep Mallolas, Principal Investigator', 'investigatorFullName': 'Juan A. Arnaiz', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}