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Sponsors and Collaborators: |
Hoffmann-La Roche Trimeris |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00488059 |
This 2 arm study will evaluate the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus optimized background in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study, eligible patients will receive Fuzeon 90mg sc b.i.d. until confirmation of response (min/max = 8/16 weeks). In the second, randomised comparator phase of the study, responders will be randomized to receive Fuzeon either 90mg sc b.i.d. or 180mg qd for a further 24 weeks. Non-responders and virological failures will be terminated from the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: enfuvirtide [Fuzeon] Drug: Optimized ARV background Drug: Integrase inhibitor |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study Evaluating the Antiviral Activity and Safety of Fuzeon in Triple-Class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care Regimen Which Includes Initiating an Integrase Inhibitor in an Expanded Access Program Plus Optimized Background |
Estimated Enrollment: | 238 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: enfuvirtide [Fuzeon]
90mg sc bid
Drug: Optimized ARV background
As prescribed
Drug: Integrase inhibitor
As prescribed
|
2: Experimental |
Drug: Optimized ARV background
As prescribed
Drug: Integrase inhibitor
As prescribed
Drug: enfuvirtide [Fuzeon]
180mg sc qd
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20837 |
Study First Received: | June 18, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00488059 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced |
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 |