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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00232908

Run by

Hoffmann-La Roche

People needed

361

Starts

2004-06-01

Expected to finish

2005-10-01

Last updated by the study team

2016-11-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• previous use of Fuzeon and/or T-1249;
• active, untreated opportunistic infection;
• inability to self-inject, unless a reliable caregiver is available to inject.

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Berkeley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — Oakland, California, United States
• Study site — Palm Springs, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Mateo, California, United States
• Study site — Tarzana, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bay Pines, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Brandon, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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