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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00232908
First received: October 4, 2005
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: enfuvirtide [Fuzeon]
Drug: ARV regimen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Enfuvirtide
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • QoL (MOS-HIV)\n [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HIV-RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4 count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 361
Study Start Date: June 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: enfuvirtide [Fuzeon]
90mg sc bid for 12 weeks
Drug: ARV regimen
As prescribed

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232908

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85012
United States, California
Bakersfield, California, United States, 93301
Berkeley, California, United States, 94705
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90073
Los Angeles, California, United States, 90026
Modesto, California, United States, 95350
Oakland, California, United States, 94609
Palm Springs, California, United States, 92262
Rancho Mirage, California, United States, 92270
San Mateo, California, United States, 94403
Tarzana, California, United States, 91356
United States, District of Columbia
Washington, District of Columbia, United States, 20017
United States, Florida
Bay Pines, Florida, United States, 33744
Boynton Beach, Florida, United States, 33426
Brandon, Florida, United States, 33511
Daytona Beach, Florida, United States, 32117
Fort Lauderdale, Florida, United States, 33334
Fort Lauderdale, Florida, United States, 33311
Fort Lauderdale, Florida, United States, 33316
Fort Myers, Florida, United States, 33901
Jacksonville, Florida, United States, 32204
Jacksonville, Florida, United States, 32206
Miami, Florida, United States, 33137
Miami Beach, Florida, United States, 33140
Miami Beach, Florida, United States, 33139
North Palm Beach, Florida, United States, 33408
Oakland Park, Florida, United States, 33334
Orlando, Florida, United States, 32806
Plantation, Florida, United States, 33317
Pompano Beach, Florida, United States, 33062
Port St Lucie, Florida, United States, 34952
Sarasota, Florida, United States, 34239
South Miami, Florida, United States, 33143
Tallahassee, Florida, United States, 32308
Tamarac, Florida, United States, 33321
Tampa, Florida, United States, 33607
Tampa, Florida, United States, 33614
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30318
Atlanta, Georgia, United States, 30312
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30342
Atlanta, Georgia, United States, 30327
Decatur, Georgia, United States, 30033
Lawrenceville, Georgia, United States, 30045
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60612
Springfield, Illinois, United States, 62703
United States, Kansas
Topeka, Kansas, United States, 66606
Wichita, Kansas, United States, 67214
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maryland
Silver Spring, Maryland, United States, 20910
United States, Michigan
Berkley, Michigan, United States, 48072-1550
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Kansas City, Missouri, United States, 64111
Kansas City, Missouri, United States, 64112
St Louis, Missouri, United States, 63139
St Louis, Missouri, United States, 63117
St Louis, Missouri, United States, 63108
United States, Montana
Butte, Montana, United States, 59701
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
East Orange, New Jersey, United States, 07018
Englewood, New Jersey, United States, 07631
Jersey City, New Jersey, United States, 07302
Newark, New Jersey, United States, 07102
Newark, New Jersey, United States, 07112
Newark, New Jersey, United States, 07103
Perth Amboy, New Jersey, United States, 08861
Somers Point, New Jersey, United States, 08244
West Orange, New Jersey, United States, 07052
United States, New York
Manhasset, New York, United States, 11030
Mt Vernon, New York, United States, 10550
New York, New York, United States, 10011
New York, New York, United States, 10016
Rochester, New York, United States, 14604
Staten Island, New York, United States, 10304
Stony Brook, New York, United States, 11794-8153
United States, North Carolina
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Akron, Ohio, United States, 44304
Cincinnati, Ohio, United States, 45206
United States, Oregon
Portland, Oregon, United States, 97209-2534
United States, Pennsylvania
Harrisburg, Pennsylvania, United States, 17110
Philadelphia, Pennsylvania, United States, 19107
Reading, Pennsylvania, United States, 19601
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Charleston, South Carolina, United States, 29425
Columbia, South Carolina, United States, 29203
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75219
Dallas, Texas, United States, 75246
Fort Worth, Texas, United States, 76104
Galveston, Texas, United States, 77555
Houston, Texas, United States, 77027
Houston, Texas, United States, 77098
Houston, Texas, United States, 77004
San Antonio, Texas, United States, 78212
United States, Virginia
Fairfax, Virginia, United States, 22030
Hampton, Virginia, United States, 23666
United States, Washington
Seattle, Washington, United States, 98104
Seattle, Washington, United States, 98109
Puerto Rico
Cagaus, Puerto Rico, 00725
Ponce, Puerto Rico, 00717-1563
San Juan, Puerto Rico, 00908
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00232908     History of Changes
Other Study ID Numbers: ML18018
Study First Received: October 4, 2005
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013