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Trial information
QUALITE study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
Status: Completed
Protocol number: ML18018
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
Brief 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.
Target sample size is 325.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. QoL (MOS-HIV)
Time frame: Baseline and Week 12
Key secondary outcomes: 1. Change from baseline in HIV-RNA Time frame: Week 12
2. Change from baseline in CD4 count Time frame: Week 12
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.
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/26/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:United States - Phoenix, AZ
- Bakersfield, CA
- Berkeley, CA
- Los Angeles, CA
- Modesto, CA
- Oakland, CA
- Palm Springs, CA
- San Mateo, CA
- Tarzana, CA
- Brandon, FL
- Daytona Beach, FL
- Fort Lauderdale, FL
- Fort Myers, FL
- Jacksonville, FL
- Miami Beach, FL
- North Palm Beach, FL
- Pompano Beach, FL
- Port St Lucie, FL
- Sarasota , FL
- South Miami, FL
- Tamarac, FL
- Tampa, FL
- Vero Beach, FL
- Atlanta, GA
- Decatur, GA
- Lawrenceville, GA
- Boise, ID
- Chicago, IL
- Topeka, KS
- Wichita, KS
- Louisville, KY
- Silver Spring, MD
- Berkley, MI
- Ypsilanti, MI
- Kansas City, MO
- St Louis, MO
- Butte, MT
- Las Vegas, NV
- East Orange, NJ
- Englewood, NJ
- Newark, NJ
- Perth Amboy, NJ
- Somers Point, NJ
- West Orange, NJ
- Mt Vernon, NY
- Rochester, NY
- Staten Island, NY
- Winston-Salem, NC
- Akron, OH
- Portland, OR
- Philadelphia, PA
- Reading, PA
- West Reading, PA
- Ponce, PR
- Austin, TX
- Dallas, TX
- Fort Worth, TX
- Houston, TX
- San Antonio, TX
- Fairfax , VA
- Hampton, VA
- Seattle, WA
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