QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
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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.
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
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
adults or adolescents at least 16 years of age;
clinically stable, treatment-experienced;
evidence of HIV-1 replication despite ongoing antiretroviral therapy;
CD4 + count greater than 50 cells/mm3.
previous use of Fuzeon and/or T-1249;
active, untreated opportunistic infection;
inability to self-inject, unless a reliable caregiver is available to inject.