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
  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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158405

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
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Bristol-Myers Squibb
Investigators
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

ClinicalTrials.gov processed this record on September 22, 2014