Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)

NCT ID: NCT00158405

Last Updated: 2008-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2006-12-31

Brief Summary

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.

Detailed Description

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 :

1. 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.

2. 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.

Conditions

HIV Infections

Keywords

HIV; Structured treatment interruption; HAART; Sub-saharian africa; Treatment Interruption; Treatment Naive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Structured Treatment Interruption

Intervention Type: PROCEDURE

Zidovudine (ZDV)

Intervention Type: DRUG

Lamivudine (3TC)

Intervention Type: DRUG

Efavirenz (EFV)

Intervention Type: DRUG

Ritonavir (NRV)

Intervention Type: DRUG

Indinavir (IDV)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Xavier Anglaret, MD

Role: STUDY_DIRECTOR

Unité INSERM 593, Université Victor Segalen Bordeaux 2

Christine Danel, MD

Role: PRINCIPAL_INVESTIGATOR

Programme PACCI, Abidjan

Roger Salamon, Pr

Role: STUDY_CHAIR

Unité INSERM 593, Université Victor Segalen Bordeaux 2

Emmanuel Bissagnene, Pr

Role: STUDY_CHAIR

CHU Treichville

Locations

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

Countries

Côte d’Ivoire

References

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.

Reference Type: BACKGROUND

PMID: 16152755 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16782488 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18986246 (View on PubMed)

Other Identifiers

ANRS 1269 TRIVACAN

Identifier Type: -

Identifier Source: org_study_id