Status:
COMPLETED
Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Universitywide AIDS Research Program
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.
Detailed Description
Some patients do not achieve an undetectable HIV viral load with an enfuvirtide (T20, Fuzeon) based antiretroviral regimen. As a consequence, enfuvirtide resistant virus can emerge. It is not yet know...
Eligibility Criteria
Inclusion
- Currently receiving continuous enfuvirtide-based antiretroviral therapy.
- Documentation of recent plasma HIV RNA level greater than the lower limit of detection (measured within the preceding 4 weeks)
- Screening plasma HIV-1 RNA level \> 1000 copies/mL.
- Negative serum pregnancy test (for women of childbearing potential) documented within the 14-day period prior to study entry.
- Subjects must be able to give written informed consent and agree to abide by the requirements of the study.
Exclusion
- Unstable HIV disease status such that interrupting any antiretroviral therapy poses significant short-term risk for disease progression (as determined by study investigators and referring primary care provider).
- Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study.
- Active hepatitis C infection requiring treatment with an interferon-based regimen.
- Evidence of active, untreated opportunistic infections or unexplained temperature which is \> 38.5°C for seven consecutive days, within 30 days prior to the first screening visit.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00187551
Start Date
May 1 2000
End Date
November 1 2005
Last Update
February 10 2011
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110