Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511368
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2007-08-01
Brief Title:
Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks
Sponsor:
Myrexis Inc
Organization:
Myrexis Inc
Study Overview
Official Title:
Phase 2 Dose-escalating P-C D-B Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety Tolerability and Efficacy of PA103001-04 Administered as Functional Monotherapy for 14 Days PART B
Status:
COMPLETED
Status Verified Date:
2010-01
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 purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients who have documented genotypic resistance to at least one major mutation from the IAS-USA list 2007of resistance mutations for NRTIs NNRTIs or PIs Patients will also be monitored for side effects and the pharmacokinetics of bevirimat will be determined
Detailed Description:
Bevirimat PA103001-04 represents a new class of antivirals that blocks HIV replication by disrupting virus maturation specifically by inhibiting a late step in the Gag processing cascade Short term 7-10 days functional monotherapy studies conducted in patients with detectable viral loads on a failing regimenhelp in determining the potency of the drug and enable dose finding This is a two part A and Brandomized placebo-controlled double-blind multiple-dose dose-escalation study in HIV treatment-experienced patients on a failing regimen harboring resistance mutations to at least one member of the NRTI NNRTI or PI classes The antiretroviral activity safety and pharmacokinetics of up to 5 different dose levels of bevirimat will be compared to placebo when added to a failing approved antiretroviral regimen The study is conducted in two parts A and B In Part A following 14 days of daily dosing patients commenced a new optimized ART regimen in addition to their randomized treatment In Part Part B dosing with the randomized treatment ends after the initial 14 days of daily dosing
Study Oversight
Has Oversight DMC:
None
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?:
None