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.

NCT00615134 — Phase 2, Completed, 29 participants, Hoffmann-La Roche
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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.

RegistryNCT00615134
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment29 (Actual)
SponsorHoffmann-La Roche (Industry)
ConditionsHIV Infections
Interventionsenfuvirtide [Fuzeon], Optimized background ARV therapy (Drug)
Datesstart 2008-01-01, primary completion 2011-06-01, completion 2011-06-01, first posted 2008-02-14, last updated 2015-01-27
Locations30 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for HIV Infections All trials of enfuvirtide [Fuzeon] All trials of Optimized background ARV therapy

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
1ExperimentalDrug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV therapy
2Active comparatorDrug: Optimized background ARV therapy
  • enfuvirtide [Fuzeon] (Drug): 90mg sc bid
  • Optimized background ARV therapy (Drug): As prescribed

+Outcome measures

Primary outcomes

  • Percentage of patients with plasma viral load <50 copies/mL [Week 24]

Secondary outcomes

  • CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. [Throughout study]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (30)

FacilityCityCountryStatus
Aulnay-sous-BoisFrance
Basse-terreFrance
BordeauxFrance
BoulogneFrance
CaenFrance
ColmarFrance
Fort-de-franceFrance
GarchesFrance
La Roche-sur-YonFrance
Le Kremlin-BicêtreFrance
Levallois-PerretFrance
LyonFrance
MarseilleFrance
NantesFrance
NiceFrance
NîmesFrance
ParisFrance
ParisFrance
ParisFrance
ParisFrance
ParisFrance
PessacFrance
Pointe à PitreFrance
PoitiersFrance
PontoiseFrance
RouenFrance
Saint-DenisFrance
Saint-PierreFrance
ToulouseFrance
TourcoingFrance

+Investigators

  • Clinical Trials, Study director, Hoffmann-La Roche