INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon

+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.

c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Enfuvirtide

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• HIV-1 infection, with virologic failure;

• on same stable HAART for >4 weeks, with viral load >1000 RNA copies/mL;

• Fuzeon-naive.

Exclusion Criteria:

• coinfection with HIV-2;

• active opportunistic infection in 4 weeks prior to screening;

• cirrhosis or severe liver failure;

• severe renal disease.