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.

January 19, 2015 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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, 75651
      • Paris, France, 75674
      • Paris, France, 75010
      • Paris, France, 75571
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with plasma viral load <50 copies/mL
Time Frame: Week 24
Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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