A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00089492

Run by

Hoffmann-La Roche

People needed

64

Starts

2004-07-01

Expected to finish

2006-06-01

Last updated by the study team

2016-11-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected adults or adolescents >=16 years of age;
• HIV-1 RNA >=5000 copies/mL;
• prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

You may not qualify if…

• history of prior use of Fuzeon or T-1249;
• female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
• current severe illness;
• currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.

Where it is running

• Study site — Hobson City, Alabama, United States
• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Union, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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