Trial information
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
Status: Completed
Protocol number: ML18596
Sponsor: Hoffmann-La Roche; Trimeris Inc.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon in HIV-1 infected, ARV treatment-experienced adults
Brief summary: The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is
58.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. Composite endpoint (pain, induration, nodules/cysts). Time frame: Throughout study
Key secondary outcomes: 1. Steady state C trough Time frame: Weekly
2. Signs and symptoms associated with Fuzeon injections Time frame: Throughout study
Inclusion criteria:
- male or female patients, >=18 years of age with HIV-1 infection;
- previously treated with antiretroviral agents.
Exclusion criteria:
- prior use of Fuzeon or T-1249;
- inability to self-inject;
- active, untreated opportunistic infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Los Angeles, CA
- South Miami, FL
- Atlanta, GA
- Chicago, IL
- St Louis, MO
- Winston-Salem, NC
- Dallas, TX
- Houston, TX
- Annandale, VA
