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.

Roche

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00615134

ML21287

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: enfuvirtide [Fuzeon]

Drug: Optimized background ARV therapy

2

Active Comparator group

Treatment:

Drug: Optimized background ARV therapy