Status:
COMPLETED
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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 stabl...
Eligibility Criteria
Inclusion
- 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
- previous use of Fuzeon and/or T-1249;
- active, untreated opportunistic infection;
- inability to self-inject, unless a reliable caregiver is available to inject.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00232908
Start Date
June 1 2004
End Date
October 1 2005
Last Update
November 2 2016
Active Locations (106)
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1
Phoenix, Arizona, United States, 85012
2
Bakersfield, California, United States, 93301
3
Berkeley, California, United States, 94705
4
Los Angeles, California, United States, 90022