This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
Unnamed facility
Sofia, Bulgaria
Percentage of participants who discontinue enfuvirtide due to adverse events\n
Time frame: Up to 102 weeks
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
Time frame: Up to 102 weeks
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
Time frame: Up to 102 weeks
Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
Time frame: Up to 28 days after discontinuation of enfuvirtide
Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
Time frame: Up to 102 weeks
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