Clinical trial NCT00232908: QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 361
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: QoL (MOS-HIV)\n
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from baseline in HIV-RNA
timeFrame: Week 12
measure: Change from baseline in CD4 count
timeFrame: Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Berkeley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Oakland
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Bay Pines
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Palm Beach
country: United States
state: Florida
city: Oakland Park
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Pompano Beach
country: United States
state: Florida
city: Port St Lucie
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Lawrenceville
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Silver Spring
country: United States
state: Maryland
city: Berkley
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: East Orange
country: United States
state: New Jersey
city: Englewood
country: United States
state: New Jersey
city: Jersey City
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Perth Amboy
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: Mt Vernon
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Winston-salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Harrisburg
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Cagaus
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: