Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Procedure: Structured Treatment Interruption Drug: Zidovudine (ZDV) Drug: Lamivudine (3TC) Drug: Efavirenz (EFV) Drug: Ritonavir (NRV) Drug: Indinavir (IDV) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- 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
- To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :
- HIV resistance to antiretroviral drugs
- Cost-utility
- Compliance to treatment
| Enrollment: | 840 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2006 |
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
- 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);
- ritonavir-indinavir, for HIV-2 infected patients, women not desiring contraception, and women with a past history of p-MTCT with nevirapine.
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 :
- Arm 1: Continuous HAART (1 of 6 patients)
- Arm 2: Fixed STI strategy (3 of 6 patients): immutable periods of 2 months on HAART / 4 months off HAART
- 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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent
- 18 years old or more
- CD4 count between 150 and 350 per mm3 (or CD4 percentage between 12.5 and 20 percent)
- no past history of curative antiretroviral therapy
- residence in Abidjan
Exclusion Criteria:
- pregnancy
- severe renal failure
- severe hepatic failure
- severe neuropsychiatric disease
Contacts and Locations| Côte D'Ivoire | |
| Centre de Prise en Charge et de Formation ACONDA | |
| Abidjan, Côte D'Ivoire | |
| Centre Intégré de Recherches Biocliniques d'Abidjan | |
| Abidjan, Côte D'Ivoire | |
| Unité de Soins Ambulatoires et de Conseil, CHU de Treichville | |
| Abidjan, Côte D'Ivoire | |
| Service des Maladies Infectieuses et Tropicales, CHU de Treichville | |
| Abidjan, Côte D'Ivoire | |
| Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine | |
| Abidjan, Côte D'Ivoire | |
| Study Director: | Xavier Anglaret, MD | Unité INSERM 593, Université Victor Segalen Bordeaux 2 |
| Principal Investigator: | Christine Danel, MD | Programme PACCI, Abidjan |
| Study Chair: | Roger Salamon, Pr | Unité INSERM 593, Université Victor Segalen Bordeaux 2 |
| Study Chair: | Emmanuel Bissagnene, Pr | CHU Treichville |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00158405 History of Changes |
| Other Study ID Numbers: | ANRS 1269 TRIVACAN |
| Study First Received: | September 7, 2005 |
| Last Updated: | December 29, 2008 |
| Health Authority: | Cote d'Ivoire: Ministry of AIDS |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV Structured treatment interruption HAART |
Sub-saharian africa Treatment Interruption Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Efavirenz Indinavir |
Ritonavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013