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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00158405
First received: September 7, 2005
Last updated: December 29, 2008
Last verified: December 2008

September 7, 2005
December 29, 2008
December 2002
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00158405 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
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

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 :

  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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Procedure: Structured Treatment Interruption
  • Drug: Zidovudine (ZDV)
  • Drug: Lamivudine (3TC)
  • Drug: Efavirenz (EFV)
  • Drug: Ritonavir (NRV)
  • Drug: Indinavir (IDV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
December 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Côte D'Ivoire
 
NCT00158405
ANRS 1269 TRIVACAN
Yes
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Bristol-Myers Squibb
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
French National Agency for Research on AIDS and Viral Hepatitis
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP