A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Trimeris
• Treatments: Enfuvirtide; HIV Integrase Inhibitors; Integrase Inhibitors

Criteria

Inclusion Criteria:

• Adult patients, >=18 years of age

• HIV-1 infection

• Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive

• GSS >= 3 ; nucleosides excluded

Exclusion Criteria:

• Adverse clinical or laboratory experience >ACTG Grade 4

• Untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen

• Malignancy requiring chemotherapy or radiotherapy