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CompletedNCT00615134Updated Jan 27, 2015

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 Phase 2 interventional study of enfuvirtide [Fuzeon] and Optimized background ARV therapy in HIV Infections, sponsored by Hoffmann-La Roche. Completed at 30 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • treatment experienced
03

In context

HIV Infections

4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 29 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • coinfection with HIV-2;
  • active opportunistic infection in 4 weeks prior to screening;
  • cirrhosis or severe liver failure;
  • severe renal disease.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    1

    Drug: enfuvirtide [Fuzeon] · Drug: Optimized background ARV therapy

  • Active comparator
    2

    Drug: Optimized background ARV therapy

Interventions

  • Drugenfuvirtide [Fuzeon]

    90mg sc bid

  • DrugOptimized background ARV therapy

    As prescribed

06

What researchers measure

Primary outcomes

  1. Percentage of patients with plasma viral load <50 copies/mL

    Time frame: Week 24

Secondary outcomes

  1. CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.

    Time frame: Throughout study

07

Study locations

30 sites
  • Aulnay Sous Bois, 93600, France
  • Basse-terre, 97100, France
  • Bordeaux, 33000, France
  • Boulogne, 62321, France
  • Caen, 14033, France
  • Colmar, 68024, France
  • Fort-de-france, 97261, France
  • Garches, 92380, France
  • La Roche Sur Yon, 85925, France
  • Le Kremlin Bicêtre, 91275, France
  • Levallois Perret, 92309, France
  • Lyon, 69317, France
  • Marseille, 13006, France
  • Nantes, 44035, France
  • Nice, 06202, France
  • Nimes, 30029, France
  • Paris, 75010, France
  • Paris, 75571, France
  • Paris, 75651, France
  • Paris, 75674, France
  • Paris, 75970, France
  • Pessac, 33600, France
  • Pointe À Pitre, 97159, France
  • Poitiers, 86021, France
  • Pontoise, 95303, France
  • Rouen, 73031, France
  • Saint Pierre, 97448, France
  • Saint-denis, 97400, France
  • Toulouse, 31052, France
  • Tourcoing, 59208, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00615134
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Feb 14, 2008
Start date
Jan 2008
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jan 27, 2015

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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