Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT00187551
Status:
COMPLETED
Last Update Posted:
2011-02-10
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: