DRUG
enfuvirtide [Fuzeon]
90mg sc bid
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
Phase
Phase 2
Enrollment
29
Locations
30
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Optimized background ARV therapy
As prescribed
Timeline
From registration to results.
First posted
Feb 14, 2008
Study start
Jan 2008
Primary completion
Jun 2011
Study completion
Jun 2011
Results posted
Not reported
Registry updated
Jan 27, 2015
Outcomes
What the study measures.
Primary outcomes
Percentage of patients with plasma viral load <50 copies/mL
Time frame · Week 24
Secondary outcomes
CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.
Time frame · Throughout study
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
30 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Aulnay-sous-Bois, France
Facility not named
Basse-terre, France
Facility not named
Bordeaux, France
Facility not named
Boulogne, France
Facility not named
Caen, France
Facility not named
Colmar, France
Facility not named
Fort-de-france, France
Facility not named
Garches, France
Facility not named
La Roche-sur-Yon, France
Facility not named
Le Kremlin-Bicêtre, France
Facility not named
Levallois-Perret, France
Facility not named
Lyon, France
Facility not named
Marseille, France
Facility not named
Nantes, France
Facility not named
Nice, France
Facility not named
Nîmes, France
Facility not named
Paris, France
Facility not named
Paris, France
Facility not named
Paris, France
Facility not named
Paris, France
Facility not named
Paris, France
Facility not named
Pessac, France
Facility not named
Pointe à Pitre, France
Facility not named
Poitiers, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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