drugset / Trial / NCT02582983

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

NCT02582983

Phase 4 Completed 23 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-02
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Enfuvirtide Peptide 90 mg Subcutaneous