Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00187551

Run by

University of California, San Francisco

People needed

25

Starts

2000-05-01

Expected to finish

2005-11-01

Last updated by the study team

2011-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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