QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
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
1 other identifier
interventional
361
2 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Jun 2004
Shorter than P25 for phase_4 hiv-infections
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 4, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedNovember 2, 2016
November 1, 2016
1.3 years
October 4, 2005
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
QoL (MOS-HIV)\n
Baseline and Week 12
Secondary Outcomes (2)
Change from baseline in HIV-RNA
Week 12
Change from baseline in CD4 count
Week 12
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Bakersfield, California, 93301, United States
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Berkeley, California, 94705, United States
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Los Angeles, California, 90022, United States
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Los Angeles, California, 90026, United States
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Los Angeles, California, 90073, United States
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Modesto, California, 95350, United States
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Oakland, California, 94609, United States
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Palm Springs, California, 92262, United States
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Rancho Mirage, California, 92270, United States
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San Mateo, California, 94403, United States
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Tarzana, California, 91356, United States
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Washington D.C., District of Columbia, 20017, United States
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Bay Pines, Florida, 33744, United States
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Boynton Beach, Florida, 33426, United States
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Brandon, Florida, 33511, United States
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Daytona Beach, Florida, 32117, United States
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Fort Lauderdale, Florida, 33311, United States
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Fort Lauderdale, Florida, 33316, United States
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Fort Lauderdale, Florida, 33334, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32204, United States
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Jacksonville, Florida, 32206, United States
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Miami, Florida, 33137, United States
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Miami Beach, Florida, 33139, United States
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Miami Beach, Florida, 33140, United States
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North Palm Beach, Florida, 33408, United States
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Oakland Park, Florida, 33334, United States
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Orlando, Florida, 32806, United States
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Plantation, Florida, 33317, United States
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Pompano Beach, Florida, 33062, United States
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Port Saint Lucie, Florida, 34952, United States
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Sarasota, Florida, 34239, United States
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South Miami, Florida, 33143, United States
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Tallahassee, Florida, 32308, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33607, United States
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Tampa, Florida, 33614, United States
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Vero Beach, Florida, 32960, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30312, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30327, United States
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Atlanta, Georgia, 30342, United States
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Decatur, Georgia, 30033, United States
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Lawrenceville, Georgia, 30045, United States
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Boise, Idaho, 83704, United States
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Chicago, Illinois, 60612, United States
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Springfield, Illinois, 62703, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40202, United States
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Silver Spring, Maryland, 20910, United States
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Berkley, Michigan, 48072-1550, United States
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Ypsilanti, Michigan, 48197, United States
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Minneapolis, Minnesota, 55404, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64112, United States
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St Louis, Missouri, 63108, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63139, United States
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Butte, Montana, 59701, United States
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Las Vegas, Nevada, 89102, United States
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East Orange, New Jersey, 07018, United States
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Englewood, New Jersey, 07631, United States
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Jersey City, New Jersey, 07302, United States
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Newark, New Jersey, 07102, United States
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Newark, New Jersey, 07103, United States
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Newark, New Jersey, 07112, United States
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Perth Amboy, New Jersey, 08861, United States
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Somers Point, New Jersey, 08244, United States
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West Orange, New Jersey, 07052, United States
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Manhasset, New York, 11030, United States
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Mount Vernon, New York, 10550, United States
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New York, New York, 10011, United States
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New York, New York, 10016, United States
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Rochester, New York, 14604, United States
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Staten Island, New York, 10304, United States
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Stony Brook, New York, 11794-8153, United States
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Winston-Salem, North Carolina, 27103, United States
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Akron, Ohio, 44304, United States
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Cincinnati, Ohio, 45206, United States
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Portland, Oregon, 97209-2534, United States
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Harrisburg, Pennsylvania, 17110, United States
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Philadelphia, Pennsylvania, 19107, United States
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Reading, Pennsylvania, 19601, United States
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West Reading, Pennsylvania, 19611, United States
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Charleston, South Carolina, 29425, United States
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Columbia, South Carolina, 29203, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75219, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Galveston, Texas, 77555, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77027, United States
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Houston, Texas, 77098, United States
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San Antonio, Texas, 78212, United States
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Fairfax, Virginia, 22030, United States
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Hampton, Virginia, 23666, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98109, United States
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Cagaus, 00725, Puerto Rico
Unknown Facility
Ponce, 00717-1563, Puerto Rico
Unknown Facility
San Juan, 00908, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2005
First Posted
October 5, 2005
Study Start
June 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
November 2, 2016
Record last verified: 2016-11