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

Roche

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Enfuvirtide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02582983

ML17819

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.