Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Res… (NCT00187551) | Clinical Trial Compass
CompletedPhase 4
Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance
United States25 participantsStarted 2000-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.