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Sponsors and Collaborators: |
Hoffmann-La Roche Trimeris |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00233883 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: enfuvirtide [Fuzeon] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety Study |
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 |
Enrollment: | 58 |
Study Completion Date: | July 2006 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 4 weeks
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2: Active Comparator |
Drug: enfuvirtide [Fuzeon]
90mg sc bid by 27G1/2" needle/syringe for 4 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
LOS ANGELES, California, United States, 90036 | |
LOS ANGELES, California, United States, 90210 | |
LOS ANGELES, California, United States, 90022 | |
LONG BEACH, California, United States, 90813 | |
United States, District of Columbia | |
WASHINGTON, District of Columbia, United States, 20009 | |
United States, Florida | |
FORT LAUDERDALE, Florida, United States, 33334 | |
SOUTH MIAMI, Florida, United States, 33143 | |
United States, Georgia | |
ATLANTA, Georgia, United States, 30309 | |
United States, Illinois | |
CHICAGO, Illinois, United States, 60612 | |
CHICAGO, Illinois, United States, 60657 | |
United States, Massachusetts | |
BOSTON, Massachusetts, United States, 02215-3318 | |
United States, Michigan | |
DETROIT, Michigan, United States, 48201 | |
United States, Missouri | |
ST LOUIS, Missouri, United States, 63139 | |
United States, North Carolina | |
WINSTON-SALEM, North Carolina, United States, 27157-1082 | |
United States, Texas | |
HOUSTON, Texas, United States, 77004 | |
DALLAS, Texas, United States, 75246 | |
United States, Virginia | |
ANNANDALE, Virginia, United States, 22003 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML18596 |
Study First Received: | October 4, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00233883 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Enfuvirtide Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Infection |
Antiviral Agents Pharmacologic Actions Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections HIV Fusion Inhibitors |