Status:
COMPLETED
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.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Eli...
Eligibility Criteria
Inclusion
- 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
- coinfection with HIV-2;
- active opportunistic infection in 4 weeks prior to screening;
- cirrhosis or severe liver failure;
- severe renal disease.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00615134
Start Date
January 1 2008
End Date
June 1 2011
Last Update
January 27 2015
Active Locations (30)
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1
Aulnay-sous-Bois, France, 93600
2
Basse-terre, France, 97100
3
Bordeaux, France, 33000
4
Boulogne, France, 62321