Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance
|HIV Infections||Other: Interruption of enfuvirtide Other: enfuvirtide interrupton||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus|
- CD4 [ Time Frame: week 24 ]
|Study Start Date:||May 2000|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Experimental: interruption of enfuvirtide
Other: Interruption of enfuvirtide
treatment interruptionOther: enfuvirtide interrupton
enfuvitide will be interrupted in patients harboring resistant virus
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 regimens.
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 genotype/phenotype evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187551
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Steven G Deeks, M.D.||University of California, San Francisco|