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



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:8/3/2016
Start Date:June 2004
End Date:October 2005

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An Open-label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-experienced Patients With HIV-1 Infection

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.


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.
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