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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
It'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
The trial was designed in two phases :
Pre-randomisation phase : 840 HAART-naive HIV-infected adults start the following continuous HAART regimen: zidovudine-lamivudine in combination with
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 :
Following the DSMB recommendation, the arm 3 has been discontinued in october 2005. The trial is continuing for patients in the arms 1 and 2.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Treatment Interruption | Procedure | |||
| Zidovudine (ZDV) | Drug | |||
| Lamivudine (3TC) | Drug | |||
| Efavirenz (EFV) | Drug | |||
| Ritonavir (NRV) | Drug | |||
| Indinavir (IDV) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of : | ||
| Percentage of patients with CD4 count over 350 per mm3 | ||
| Incidence of severe morbidity | ||
| Incidence of mortality |
| Measure | Description | Time Frame |
|---|---|---|
| To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of : | ||
| HIV resistance to antiretroviral drugs | ||
| Cost-utility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Anglaret, MD | Unité INSERM 593, Université Victor Segalen Bordeaux 2 | Study Director |
| Christine Danel, MD | Programme PACCI, Abidjan | Principal Investigator |
| Roger Salamon, Pr | Unité INSERM 593, Université Victor Segalen Bordeaux 2 | Study Chair |
| Emmanuel Bissagnene, Pr | CHU Treichville | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Prise en Charge et de Formation ACONDA | Abidjan | Côte d’Ivoire | ||||
| Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16152755 | Background | 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. | |
| 16782488 |
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| Compliance to treatment |
| Abidjan |
| Côte d’Ivoire |
| Centre Intégré de Recherches Biocliniques d'Abidjan | Abidjan | Côte d’Ivoire |
| Service des Maladies Infectieuses et Tropicales, CHU de Treichville | Abidjan | Côte d’Ivoire |
| Unité de Soins Ambulatoires et de Conseil, CHU de Treichville | Abidjan | Côte d’Ivoire |
| 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. |
| 18986246 | Result | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000097042 | Treatment Interruption |
| D015215 | Zidovudine |
| D019259 | Lamivudine |
| C098320 | efavirenz |
| D019438 | Ritonavir |
| D019469 | Indinavir |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D001294 | Attitude to Health |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D011725 | Pyridines |
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