Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance
|ClinicalTrials.gov Identifier: NCT00187551|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Other: Interruption of enfuvirtide Other: enfuvirtide interrupton||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus|
|Study Start Date :||May 2000|
|Primary Completion Date :||November 2005|
|Study Completion Date :||November 2005|
Experimental: interruption of enfuvirtide
Other: Interruption of enfuvirtide
treatment interruptionOther: enfuvirtide interrupton
enfuvitide will be interrupted in patients harboring resistant virus
- CD4 [ Time Frame: week 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|