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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
As prescribed
180mg sc once daily for 48 weeks
90mg sc bid for 48 weeks
Unnamed facility
Hobson City, Alabama, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
North Miami Beach, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Sarasota, Florida, United States
...and 17 more locations
Viral load.\n\n
Time frame: Week 48
CD4 lymphocyte count.
Time frame: Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
Time frame: Throughout study
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