Trial information
INDEED Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1)
Status: Completed
Protocol number: ML18242
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of an optimized background antiretroviral regimen (OB) compared with OB associated with Fuzeon on virological success in previously treated patients with HIV-1
Brief summary: All patients will receive an initial 28 week induction treatment with Fuzeon + OB, after which patients with undetectable viremia (<50 copies/mL) will be randomized to continue Fuzeon + OB or receive only the OB. The study will compare the efficacy and safety of continued Fuzeon + OB therapy versus OB alone at 52 weeks, in patients with HIV-1 infection. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 410.
Study phase: III
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. Efficacy: Percentage of randomized patients without maintenance failure and having a plasma viral load< 50 copies/mL at Week 52.
Key secondary outcomes: 1. Efficacy: Virologic responders with plasma viral load <=50 L, <=200 and <=400 copies/mL during induction and maintenance periods; Safety: Adverse events; injection-site reactions
Inclusion criteria:
- adult patients >=18 years of age;
- HIV-1 infection;
- prior experience with >=2 of the 3 following classes of ARV drugs: nucleoside reverse transcriptase inhibitor, non-nucleoside reverse transcriptase inhibitor, and protease inhibitor;
- current treatment with highly active antiretroviral therapy (HAART) for >=3 months;
- plasma viral load between 1,000 and 100,000 copies/mL;
- CD4 cell count >50 cells/mm3.
Exclusion criteria:
- HIV-2 coinfection;
- prior exposure to Fuzeon;
- active opportunistic infection within 1 month of study entry.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2004
Trial registration date: 08/29/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
France
- Argenteuil
- Avignon
- Basse-Terre
- Bobigny
- Bordeaux
- Boulogne
- Caen
- Colmar
- Creteil
- Fort-De-France
- Garches
- Lagny-Sur-Marne
- Levallois Perret
- Lyon
- Marseille
- Montpellier
- Nantes
- Nice
- Nimes
- Paris
- Perpignan
- Pontoise
- Rennes
- Saint Pierre
- Saint-Denis
- Saint-Dizier
- Strasbourg
- Toulouse
- Villejuif
