Overview

WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
Trimeris
Treatments:
Enfuvirtide
Criteria
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.