Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00158405
Status:
COMPLETED
Last Update Posted:
2008-12-30
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097042', 'term': 'Treatment Interruption'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C098320', 'term': 'efavirenz'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D019469', 'term': 'Indinavir'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001294', 'term': 'Attitude to Health'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-29', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :'}, {'measure': 'Percentage of patients with CD4 count over 350 per mm3'}, {'measure': 'Incidence of severe morbidity'}, {'measure': 'Incidence of mortality'}], 'secondaryOutcomes': [{'measure': 'To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :'}, {'measure': 'HIV resistance to antiretroviral drugs'}, {'measure': 'Cost-utility'}, {'measure': 'Compliance to treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Structured treatment interruption', 'HAART', 'Sub-saharian africa', 'Treatment Interruption', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '16152755', 'type': 'BACKGROUND', 'citation': "Moh R, Danel C, Sorho S, Sauvageot D, Anzian A, Minga A, Gomis OB, Konga C, Inwoley A, Gabillard D, Bissagnene E, Salamon R, Anglaret X. Haematological changes in adults receiving a zidovudine-containing HAART regimen in combination with cotrimoxazole in Cote d'Ivoire. Antivir Ther. 2005;10(5):615-24. doi: 10.1177/135965350501000510."}, {'pmid': '16782488', 'type': 'RESULT', 'citation': 'Danel C, Moh R, Minga A, Anzian A, Ba-Gomis O, Kanga C, Nzunetu G, Gabillard D, Rouet F, Sorho S, Chaix ML, Eholie S, Menan H, Sauvageot D, Bissagnene E, Salamon R, Anglaret X; Trivacan ANRS 1269 trial group. CD4-guided structured antiretroviral treatment interruption strategy in HIV-infected adults in west Africa (Trivacan ANRS 1269 trial): a randomised trial. Lancet. 2006 Jun 17;367(9527):1981-9. doi: 10.1016/S0140-6736(06)68887-9.'}, {'pmid': '18986246', 'type': 'RESULT', 'citation': 'Danel C, Moh R, Chaix ML, Gabillard D, Gnokoro J, Diby CJ, Toni T, Dohoun L, Rouzioux C, Bissagnene E, Salamon R, Anglaret X; Trivacan ANRS 1269 Trial Group. Two-months-off, four-months-on antiretroviral regimen increases the risk of resistance, compared with continuous therapy: a randomized trial involving West African adults. J Infect Dis. 2009 Jan 1;199(1):66-76. doi: 10.1086/595298.'}]}, 'descriptionModule': {'briefSummary': 'Interrupting HAART during limited periods of time ("structured treatment interruption : STI") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in industrialised countries. This trial aim at assessing the benefits and risks of two different STI strategies in West Africa.', 'detailedDescription': "The objective of this study is to assess the non-inferiority of two strategies of structured treatment interruption (STI) of highly active antiretroviral treatment (HAART) compared with a continuous HAART.\n\nIt's a multicentric open labeled randomised non-inferiority trial, which takes place in 5 health care centres in Abidjan, the economic capital city of Cote d'Ivoire\n\nThe trial was designed in two phases :\n\n1. Pre-randomisation phase : 840 HAART-naive HIV-infected adults start the following continuous HAART regimen: zidovudine-lamivudine in combination with\n\n * preferably efavirenz, for HIV-1 infected men, and HIV-1 infected women with an effective contraception and no history of nevirapine-containing p-MTCT (prevention of mother to child transmission);\n * ritonavir-indinavir, for HIV-2 infected patients, women not desiring contraception, and women with a past history of p-MTCT with nevirapine.\n2. Trial phase : After at least six months on continuous HAART in the pre-randomisation phase, patients who meet success criteria (CD4 count over 350/mm3, undetectable viral load, absence of current opportunistic infection) are randomised into three arms :\n\n * Arm 1: Continuous HAART (1 of 6 patients)\n * Arm 2: Fixed STI strategy (3 of 6 patients): immutable periods of 2 months on HAART / 4 months off HAART\n * Arm 3: CD4-guided STI strategy (2 of 6 patients): unlimited interruption of HAART, and then re-introduction/re-interruption guided by the evolution of the CD4 count.\n\nFollowing the DSMB recommendation, the arm 3 has been discontinued in october 2005. The trial is continuing for patients in the arms 1 and 2."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* 18 years old or more\n* CD4 count between 150 and 350 per mm3 (or CD4 percentage between 12.5 and 20 percent)\n* no past history of curative antiretroviral therapy\n* residence in Abidjan\n\nExclusion Criteria:\n\n* pregnancy\n* severe renal failure\n* severe hepatic failure\n* severe neuropsychiatric disease'}, 'identificationModule': {'nctId': 'NCT00158405', 'briefTitle': 'Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Multicentric Randomised Controlled Trial Assessing the Efficacy of Two Strategies of Structured Treatment Interruption of Highly Active Antiretroviral Therapy (HAART) Compared With a Continuous HAART in HIV- Infected Adults in Abidjan', 'orgStudyIdInfo': {'id': 'ANRS 1269 TRIVACAN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Structured Treatment Interruption', 'type': 'PROCEDURE'}, {'name': 'Zidovudine (ZDV)', 'type': 'DRUG'}, {'name': 'Lamivudine (3TC)', 'type': 'DRUG'}, {'name': 'Efavirenz (EFV)', 'type': 'DRUG'}, {'name': 'Ritonavir (NRV)', 'type': 'DRUG'}, {'name': 'Indinavir (IDV)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Centre de Prise en Charge et de Formation ACONDA', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': "Centre Intégré de Recherches Biocliniques d'Abidjan", 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Service des Maladies Infectieuses et Tropicales, CHU de Treichville', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Unité de Soins Ambulatoires et de Conseil, CHU de Treichville', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}], 'overallOfficials': [{'name': 'Xavier Anglaret, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unité INSERM 593, Université Victor Segalen Bordeaux 2'}, {'name': 'Christine Danel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Programme PACCI, Abidjan'}, {'name': 'Roger Salamon, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Unité INSERM 593, Université Victor Segalen Bordeaux 2'}, {'name': 'Emmanuel Bissagnene, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Treichville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}]}}}