Trial information
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.
Status: Recruiting
Protocol number: ML21287
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
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 receive 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 Fuzeon, in the case of new virological failure. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 100.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. Percentage of patients with plasma viral load <50 copies/mL Time frame: Week 24
Key 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
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2008
Trial registration date: 01/30/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Aulnay Sous Bois
- Basse-Terre
- Bordeaux
- Boulogne
- Caen
- Colmar
- Fort-De-France
- Garches
- La Roche Sur Yon
- Le Kremlin Bicêtre
- Levallois Perret
- Lyon
- Marseille
- Nantes
- Nice
- Nimes
- Paris
- Pessac
- Pointe À Pitre
- Poitiers
- Pontoise
- Rouen
- Saint Pierre
- Saint-Denis
- Toulouse
- Tourcoing
