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

Stopped early · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00488059

Run by

Hoffmann-La Roche

People needed

29

Starts

2007-06-01

Expected to finish

2008-10-01

Last updated by the study team

2011-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, >=18 years of age
• HIV-1 infection
• Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive
• GSS >= 3 ; nucleosides excluded

You may not qualify if…

• 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

Where it is running

• Study site — Hobson City, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — Stanford, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — North Palm Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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