A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
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.