Clinical Trials

MainTitle

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
Hoffmann-La Roche


Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT00615134

First received: January 30, 2008
Last updated: January 19, 2015
Last Verified: January 2015
History of Changes
Purpose

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

Study Type: Interventional
Study Design: 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.

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 ]
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 ]

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: enfuvirtide [Fuzeon]

90mg sc bid

Drug: Optimized background ARV therapy

As prescribed

Active Comparator: 2

Drug: Optimized background ARV therapy

As prescribed

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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, 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

Investigators

Study Director: Clinical Trials Hoffmann-La Roche
More Information

More Information


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: January 19, 2015  

Keywords provided by Hoffmann-La Roche:

treatment experienced

Additional relevant MeSH terms:
HIV Infections
Enfuvirtide

ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.