Overview

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.