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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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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.

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

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :
  2. Percentage of patients with CD4 count over 350 per mm3
  3. Incidence of severe morbidity
  4. Incidence of mortality

Secondary Outcome Measures :
  1. To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :
  2. HIV resistance to antiretroviral drugs
  3. Cost-utility
  4. Compliance to treatment

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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
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
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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