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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615134
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: enfuvirtide [Fuzeon] Drug: Optimized background ARV therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Arm Intervention/treatment
Experimental: 1 Drug: enfuvirtide [Fuzeon]
90mg sc bid

Drug: Optimized background ARV therapy
As prescribed

Active Comparator: 2 Drug: Optimized background ARV therapy
As prescribed

Primary Outcome Measures :
  1. Percentage of patients with plasma viral load <50 copies/mL [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615134

Aulnay Sous Bois, France, 93600
Basse-terre, France, 97100
Bordeaux, France, 33000
Boulogne, France, 62321
Caen, France, 14033
Colmar, France, 68024
Fort-de-france, France, 97261
Garches, France, 92380
La Roche Sur Yon, France, 85925
Le Kremlin Bicêtre, France, 91275
Levallois Perret, France, 92309
Lyon, France, 69317
Marseille, France, 13006
Nantes, France, 44035
Nice, France, 06202
Nimes, France, 30029
Paris, France, 75010
Paris, France, 75571
Paris, France, 75651
Paris, France, 75674
Paris, France, 75970
Pessac, France, 33600
Pointe À Pitre, France, 97159
Poitiers, France, 86021
Pontoise, France, 95303
Rouen, France, 73031
Saint Pierre, France, 97448
Saint-denis, France, 97400
Toulouse, France, 31052
Tourcoing, France, 59208
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00615134     History of Changes
Other Study ID Numbers: ML21287
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Hoffmann-La Roche:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents