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.

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV therapy

• Registration Number: NCT00615134
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

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Exclusion Criteria

• coinfection with HIV-2;
• active opportunistic infection in 4 weeks prior to screening;
• cirrhosis or severe liver failure;
• severe renal disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	enfuvirtide [Fuzeon]	-
1	Optimized background ARV therapy	-
2	Optimized background ARV therapy	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with plasma viral load <50 copies/mL	Week 24

Secondary Outcome Measures

Name	Time	Method
CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.	Throughout study