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.
NCT ID: NCT00615134
Last Updated: 2015-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2008-01-31
2011-06-30
Brief Summary
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\+ 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
enfuvirtide [Fuzeon]
90mg sc bid
Optimized background ARV therapy
As prescribed
2
Optimized background ARV therapy
As prescribed
Interventions
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enfuvirtide [Fuzeon]
90mg sc bid
Optimized background ARV therapy
As prescribed
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection, with virologic failure;
* on same stable HAART for \>4 weeks, with viral load \>1000 RNA copies/mL;
* Fuzeon-naive.
Exclusion Criteria
* active opportunistic infection in 4 weeks prior to screening;
* cirrhosis or severe liver failure;
* severe renal disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Aulnay-sous-Bois, , France
Basse-terre, , France
Bordeaux, , France
Boulogne, , France
Caen, , France
Colmar, , France
Fort-de-france, , France
Garches, , France
La Roche-sur-Yon, , France
Le Kremlin-Bicêtre, , France
Levallois-Perret, , France
Lyon, , France
Marseille, , France
Nantes, , France
Nice, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pessac, , France
Pointe à Pitre, , France
Poitiers, , France
Pontoise, , France
Rouen, , France
Saint-Denis, , France
Saint-Pierre, , France
Toulouse, , France
Tourcoing, , France
Countries
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Other Identifiers
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ML21287
Identifier Type: -
Identifier Source: org_study_id
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