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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: ARV regimen; Drug: enfuvirtide [Fuzeon]

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Cagaus, Puerto Rico, 00725
  • Ponce, Puerto Rico, 00717-1563
  • San Juan, Puerto Rico, 00908
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
  • California
    • Bakersfield, California, United States, 93301
    • Berkeley, California, United States, 94705
    • Los Angeles, California, United States, 90073
    • Los Angeles, California, United States, 90022
    • 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
  • District of Columbia
    • Washington, District of Columbia, United States, 20017
  • 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
  • Georgia
    • Atlanta, Georgia, United States, 30342
    • Atlanta, Georgia, United States, 30308
    • Atlanta, Georgia, United States, 30309
    • Atlanta, Georgia, United States, 30312
    • Atlanta, Georgia, United States, 30318
    • Atlanta, Georgia, United States, 30327
    • Decatur, Georgia, United States, 30033
    • Lawrenceville, Georgia, United States, 30045
  • Idaho
    • Boise, Idaho, United States, 83704
  • Illinois
    • Chicago, Illinois, United States, 60612
    • Springfield, Illinois, United States, 62703
  • Kansas
    • Topeka, Kansas, United States, 66606
    • Wichita, Kansas, United States, 67214
  • Kentucky
    • Louisville, Kentucky, United States, 40202
  • Maryland
    • Silver Spring, Maryland, United States, 20910
  • Michigan
    • Berkley, Michigan, United States, 48072-1550
    • Ypsilanti, Michigan, United States, 48197
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
  • Missouri
    • Kansas City, Missouri, United States, 64111
    • Kansas City, Missouri, United States, 64112
    • St Louis, Missouri, United States, 63139
    • St Louis, Missouri, United States, 63108
    • St Louis, Missouri, United States, 63117
  • Montana
    • Butte, Montana, United States, 59701
  • Nevada
    • Las Vegas, Nevada, United States, 89102
  • 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, 07103
    • Newark, New Jersey, United States, 07112
    • Perth Amboy, New Jersey, United States, 08861
    • Somers Point, New Jersey, United States, 08244
    • West Orange, New Jersey, United States, 07052
  • New York
    • Manhasset, New York, United States, 11030
    • Mt Vernon, New York, United States, 10550
    • New York, New York, United States, 10016
    • New York, New York, United States, 10011
    • Rochester, New York, United States, 14604
    • Staten Island, New York, United States, 10304
    • Stony Brook, New York, United States, 11794-8153
  • North Carolina
    • Winston-salem, North Carolina, United States, 27103
  • Ohio
    • Akron, Ohio, United States, 44304
    • Cincinnati, Ohio, United States, 45206
  • Oregon
    • Portland, Oregon, United States, 97209-2534
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
    • Philadelphia, Pennsylvania, United States, 19107
    • Reading, Pennsylvania, United States, 19601
    • West Reading, Pennsylvania, United States, 19611
  • South Carolina
    • Charleston, South Carolina, United States, 29425
    • Columbia, South Carolina, United States, 29203
  • Texas
    • Austin, Texas, United States, 78705
    • Dallas, Texas, United States, 75246
    • Dallas, Texas, United States, 75219
    • Fort Worth, Texas, United States, 76104
    • Galveston, Texas, United States, 77555
    • Houston, Texas, United States, 77004
    • Houston, Texas, United States, 77027
    • Houston, Texas, United States, 77098
    • San Antonio, Texas, United States, 78212
  • Virginia
    • Fairfax, Virginia, United States, 22030
    • Hampton, Virginia, United States, 23666
  • Washington
    • Seattle, Washington, United States, 98104
    • Seattle, Washington, United States, 98109

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: ARV regimen; As prescribed; Drug: enfuvirtide [Fuzeon]; 90mg sc bid for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QoL (MOS-HIV)\n	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HIV-RNA	Week 12
Change from baseline in CD4 count	Week 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 4, 2005
• First Posted (Estimate): October 5, 2005

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: ML18018