Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
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ClinicalTrials.gov Identifier: NCT00158405 |
Recruitment Status
:
Completed
First Posted
: September 12, 2005
Last Update Posted
: December 30, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Procedure: Structured Treatment Interruption Drug: Zidovudine (ZDV) Drug: Lamivudine (3TC) Drug: Efavirenz (EFV) Drug: Ritonavir (NRV) Drug: Indinavir (IDV) | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 840 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2002 |
Actual Study Completion Date : | December 2006 |

- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158405
Côte D'Ivoire | |
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 | |
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 |
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 |
Publications of Results:
Other Publications:
ClinicalTrials.gov Identifier: | NCT00158405 History of Changes |
Other Study ID Numbers: |
ANRS 1269 TRIVACAN |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | December 30, 2008 |
Last Verified: | December 2008 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Indinavir Lamivudine Zidovudine Efavirenz HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers |