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

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00158405
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Study Completion: 2006-12
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-29
• Last Update Posted: 2008-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Cost-utility
To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :
HIV resistance to antiretroviral drugs
Compliance to treatment

Trial Locations

Locations (5)

Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine; 🇨🇮 Abidjan, 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

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