Conditions: HIV Infections
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).

Interventions: intervention 1: Enfuvirtide
Intervention descriptions: intervention 1: All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.

Protocol document: