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.
A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.
1 other identifier
interventional
29
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
Started Jan 2008
Typical duration for phase_2 hiv-infections
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 30, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJanuary 27, 2015
January 1, 2015
3.4 years
January 30, 2008
January 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with plasma viral load <50 copies/mL
Week 24
Secondary Outcomes (1)
CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- coinfection with HIV-2;
- active opportunistic infection in 4 weeks prior to screening;
- cirrhosis or severe liver failure;
- severe renal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Aulnay-sous-Bois, 93600, France
Unknown Facility
Basse-terre, 97100, France
Unknown Facility
Bordeaux, 33000, France
Unknown Facility
Boulogne, 62321, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Fort-de-france, 97261, France
Unknown Facility
Garches, 92380, France
Unknown Facility
La Roche-sur-Yon, 85925, France
Unknown Facility
Le Kremlin-Bicêtre, 91275, France
Unknown Facility
Levallois-Perret, 92309, France
Unknown Facility
Lyon, 69317, France
Unknown Facility
Marseille, 13006, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Paris, 75010, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Pessac, 33600, France
Unknown Facility
Pointe à Pitre, 97159, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Pontoise, 95303, France
Unknown Facility
Rouen, 73031, France
Unknown Facility
Saint-Denis, 97400, France
Unknown Facility
Saint-Pierre, 97448, France
Unknown Facility
Toulouse, 31052, France
Unknown Facility
Tourcoing, 59208, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2008
First Posted
February 14, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 27, 2015
Record last verified: 2015-01