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: October 20, 2014
Last verified: October 2014

January 30, 2008
October 20, 2014
January 2008
June 2011   (final data collection date for primary outcome measure)
Percentage of patients with plasma viral load <50 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00615134 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Optimized background ARV therapy
    As prescribed
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid
  • Experimental: 1
    Interventions:
    • Drug: Optimized background ARV therapy
    • Drug: enfuvirtide [Fuzeon]
  • Active Comparator: 2
    Intervention: Drug: Optimized background ARV therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00615134
ML21287
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP