DRUG
ARV regimen
As prescribed
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
Status
Completed
Phase
Phase 4
Enrollment
361
Locations
106
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
enfuvirtide [Fuzeon]
90mg sc bid for 12 weeks
Timeline
From registration to results.
First posted
Oct 5, 2005
Study start
Jun 2004
Primary completion
Oct 2005
Study completion
Oct 2005
Results posted
Not reported
Registry updated
Nov 2, 2016
Outcomes
What the study measures.
Primary outcomes
QoL (MOS-HIV)\n
Time frame · Baseline and Week 12
Secondary outcomes
Change from baseline in HIV-RNA
Time frame · Week 12
Change from baseline in CD4 count
Time frame · Week 12
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
106 registered sites.
Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Phoenix, Arizona, United States
Facility not named
Bakersfield, California, United States
Facility not named
Berkeley, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Modesto, California, United States
Facility not named
Oakland, California, United States
Facility not named
Palm Springs, California, United States
Facility not named
Rancho Mirage, California, United States
Facility not named
San Mateo, California, United States
Facility not named
Tarzana, California, United States
Facility not named
Washington D.C., District of Columbia, United States
Facility not named
Bay Pines, Florida, United States
Facility not named
Boynton Beach, Florida, United States
Facility not named
Brandon, Florida, United States
Facility not named
Daytona Beach, Florida, United States
Facility not named
Fort Lauderdale, Florida, United States
Facility not named
Fort Lauderdale, Florida, United States
Facility not named
Fort Lauderdale, Florida, United States
Facility not named
Fort Myers, Florida, United States
Facility not named
Jacksonville, Florida, United States
Facility not named
Jacksonville, Florida, United States
Facility not named
Miami, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Enfuvirtide.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.