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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00615134
First received: January 30, 2008
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
HIV Infections
Drug: Optimized background ARV therapy
Drug: enfuvirtide [Fuzeon]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with plasma viral load <50 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Optimized background ARV therapy
As prescribed
Drug: enfuvirtide [Fuzeon]
90mg sc bid
Active Comparator: 2 Drug: Optimized background ARV therapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615134

Locations
France
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, 75970
Paris, France, 75674
Paris, France, 75010
Paris, France, 75571
Paris, France, 75651
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00615134     History of Changes
Other Study ID Numbers: ML21287
Study First Received: January 30, 2008
Last Updated: August 26, 2014
Health Authority: France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Keywords provided by Hoffmann-La Roche:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014