Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Interruption of enfuvirtide (Drug)
Status: Active, not recruiting
Sponsored by: University of California, San Francisco
Official(s) and/or principal investigator(s):
Steven G Deeks, M.D., Principal Investigator, Affiliation: University of California, San Francisco
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
Official title: Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
resistance assays at weeks 4, 12, 24, 48 after enfuvirtide interruption
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 known if enfuvirtide has continued virologic or immunologic benefit after the
drug-resistant variant emerges. Interrupting enfuvirtide may reduce the accumulation of
enfuvirtide mutations and may allow for a potent response of enfuvirtide with future
Subjects must have evidence of viral replication (HIV RNA > 1,000 copies/ml on two
consecutive measurements) while on a stable antiretroviral regimen containing enfuvirtide.
Patients will then interrupt enfuvirtide while continuing all other antiretroviral agents.
Subjects will be seen weekly for four weeks, every two weeks for an additional 8 weeks, and
then every four weeks through week 48.
Plasma HIV RNA levels and CD4+/CD8+ T cell counts will be measured in real time at each
visit, and provided to the referring primary care physician. Subjects will be allowed to
resume enfuvirtide at any time during the course of this study. Subjects will be encouraged
to resume enfuvirtide (with or without modifying the background regimen) if plasma HIV RNA
levels increase by > 0. 5 log on two consecutive occasions. Subjects are seen every four
weeks for 24 weeks after enfuvirtide is resumed.
Plasma will be collected at those visits for HIV RNA and stored for retrospective
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- 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
Locations and Contacts
San Francisco General Hospital, San Francisco, California 94110, United States
Starting date: May 2000
Last updated: June 16, 2006