This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
326
90mg sc bid by Biojector 2000 NFID for 8 weeks
90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Fountain Valley, California, United States
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Hayward, California, United States
Unnamed facility
Composite endpoint (pain, induration, nodules/cysts)
Time frame: Throughout study
AEs and ISRs
Time frame: Throughout study
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Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
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Palm Springs, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Santa Clara, California, United States
...and 34 more locations