Roche trials database

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

Co-sponsors:

• 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

Conditions:

• 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

Anticipated start date:

August, 2005

Trial registration date:

14.10.2005

Date last updated:

22.01.2010

This trial was conducted at the following locations:

U.S.A.

• LONG BEACH, CA
• LOS ANGELES, CA
• WASHINGTON, DC
• FORT LAUDERDALE, FL
• SOUTH MIAMI, FL
• ATLANTA, GA
• CHICAGO, IL
• BOSTON, MA
• DETROIT, MI
• ST LOUIS, MO
• WINSTON-SALEM, NC
• DALLAS, TX
• HOUSTON, TX
• ANNANDALE, VA

Link to trial result