WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
NCT00233883 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2015-11-03
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.
Conditions
- HIV Infections
Interventions
- DRUG
-
enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 4 weeks
- DRUG
-
enfuvirtide [Fuzeon]
90mg sc bid by 27G1/2" needle/syringe for 4 weeks
Sponsors & Collaborators
-
Trimeris
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2006-07-31
- Completion
- 2006-07-31
Countries
- United States
Study Locations
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