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Completed

NCT Number: NCT00158405

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Intégré de Recherches Biocliniques d'Abidjan, Abidjan, Côte d’Ivoire

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About this study

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 :

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Treatment Interruption

Procedure

Zidovudine (ZDV)

Drug

Lamivudine (3TC)

Drug

Efavirenz (EFV)

Drug

Ritonavir (NRV)

Drug

Indinavir (IDV)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Dec 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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