A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection

An Open-Label Safety Trial of Enfuvirtide (T-20/RO 29-9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiviral Regimen in Thai Patients With Advanced HIV Infection

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.

Inclusion Criteria:

• Individuals at least 16 years of age infected with HIV-1
• CD4 lymphocyte count less than equal to (<=) 100 cells per cubic millimeter (cells/mm^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
• Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens

Exclusion Criteria:

• Evidence of ongoing alcohol and/or drug or substance abuse
• Prior non-adherence to antiretroviral treatment regimens
• Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.