QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

Summary

This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start

2004-06

Primary completion

2005-10

Completion

2005-10

Drugs

Indications