WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: enfuvirtide [Fuzeon] (Drug); enfuvirtide [Fuzeon] (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
Official 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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study
Primary outcome: Composite endpoint (pain, induration, nodules/cysts).
Secondary outcome: Steady state C troughSigns and symptoms associated with Fuzeon injections
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
LOS ANGELES, California 90036, United States
LOS ANGELES, California 90210, United States
FORT LAUDERDALE, Florida 33334, United States
SOUTH MIAMI, Florida 33143, United States
ATLANTA, Georgia 30309, United States
CHICAGO, Illinois 60612, United States
CHICAGO, Illinois 60657, United States
ST LOUIS, Missouri 63139, United States
WINSTON-SALEM, North Carolina 27157-1082, United States
HOUSTON, Texas 77004, United States
DALLAS, Texas 75246, United States
ANNANDALE, Virginia 22003, United States
Additional Information
Ending date: July 2006
Last updated: June 17, 2008
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