Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00632073
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2008-01-24
Brief Title:
Effect of Vicriviroc on HIV Ribonucleic Acid RNA Levels in Cerebrospinal Fluid Study P05241
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Effect of Vicriviroc on HIV RNA Levels in Cerebrospinal Fluid
Status:
COMPLETED
Status Verified Date:
2015-02
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:
Vicriviroc vye-kri-VYE-rock is an investigational drug not yet approved by Government Regulatory Authorities for commercial use that belongs to a new class of drugs called CCR5 receptor blockers This group of drugs blocks one of the ways HIV enters T-cells the cells that fight infection Previous studies in HIV treatment-experienced patients have shown that vicriviroc is safe and effective The purpose of this study is to determine the effect of vicriviroc on HIV RNA levels in cerebrospinal fluid CSF
Detailed Description:
This is a nonrandomized open-label multicenter study to investigate the HIV antiviral response in CSF when vicriviroc is added for 2 weeks to the subjects failing antiretroviral background regimen The primary efficacy endpoint of this study is the mean change in log10 CSF HIV RNA from baseline at Week 2 The secondary efficacy endpoint is the proportion of subjects achieving CSF HIV RNA 50 copiesmL at Week 2 At Week 2 the subjects background regimen will be optimized and vicriviroc continued up to Week 24 After completing Week 24 of the study subjects will be offered the option to continue on open-label VCV 30 mg once daily if appropriate until commercially available or until the sponsor terminates the clinical development of VCV Subjects who discontinue vicriviroc for any reason will be requested to participate in long-term follow up
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