Clinical trial NCT00615134: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: treatment experienced
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of patients with plasma viral load <50 copies/mL
timeFrame: Week 24
Secondary outcomes:
measure: CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aulnay Sous Bois
country: France
city: Basse-terre
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Caen
country: France
city: Colmar
country: France
city: Fort-de-france
country: France
city: Garches
country: France
city: La Roche Sur Yon
country: France
city: Le Kremlin Bicêtre
country: France
city: Levallois Perret
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nimes
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Pointe À Pitre
country: France
city: Poitiers
country: France
city: Pontoise
country: France
city: Rouen
country: France
city: Saint Pierre
country: France
city: Saint-denis
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: