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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Enfuvirtide

Criteria

Inclusion Criteria:

• adults or adolescents at least 16 years of age;

• HIV-1 infection;

• clinically stable, treatment-experienced;

• evidence of HIV-1 replication despite ongoing antiretroviral therapy;

• CD4 + count greater than 50 cells/mm3.

Exclusion Criteria:

• previous use of Fuzeon and/or T-1249;

• active, untreated opportunistic infection;

• inability to self-inject, unless a reliable caregiver is available to inject.