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

NCT00158405 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2008-12-30

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

PROCEDURE

Structured Treatment Interruption

DRUG

Zidovudine (ZDV)

DRUG

Lamivudine (3TC)

DRUG

Efavirenz (EFV)

DRUG

Ritonavir (NRV)

DRUG

Indinavir (IDV)

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Xavier Anglaret, MD · Unité INSERM 593, Université Victor Segalen Bordeaux 2

  • Christine Danel, MD · Programme PACCI, Abidjan

  • Roger Salamon, Pr · Unité INSERM 593, Université Victor Segalen Bordeaux 2

  • Emmanuel Bissagnene, Pr · CHU Treichville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Completion
2006-12-31

Countries

  • Côte d’Ivoire

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00158405 on ClinicalTrials.gov