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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Bristol-Myers Squibb
• Treatments: Efavirenz; Indinavir; Lamivudine; Ritonavir; Zidovudine

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