This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
Unnamed facility
Bangkok, Thailand
Unnamed facility
Bangkok, Thailand
Unnamed facility
Bangkok, Thailand
Unnamed facility
Chiang Mai, Thailand
Unnamed facility
Nonthaburi, Thailand
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.
Time frame: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Number of Participants With Premature Withdrawal Due to Adverse Events
Time frame: Up to 96 weeks
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