Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00551330
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2007-10-29
Brief Title:
Vicriviroc in HIVR5X4-Treatment Experienced Subjects Study P05057AM5COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Vicriviroc in Combination Treatment With an Optimized ART Regimen in Treatment-Experienced Subjects With R5X4 HIV Infection VICTOR-E2 Protocol No P05057
Status:
COMPLETED
Status Verified Date:
2015-12
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 smaller studies in HIV treatment-experienced patients have shown that vicriviroc is safe and effective The purpose of this study is to investigate in subjects with detectable dualmixed CCR5CXCR4-tropic HIV whether vicriviroc when added to other appropriate HIV drugs can decrease the level of HIV viral load in the blood and that it is well tolerated
This is a randomized double-blind placebo-controlled parallel-group multi-center study of vicriviroc maleate in HIV subjects infected with dualmixed CCR5CXCR4-tropic virus and who have documented resistance to at least 2 of the 3 antiretroviral drug classes NRTI NNRTI or PI or at least 6 months experience with at least 2 of the following one NRTI one NNRTI or one PI excluding low-dose ritonavir and failure on their current stable regimen The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening history of prior antiretroviral drug use by the patient and drug toxicity Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment An interim analysis will be performed when all subjects have completed 24 weeks of treatment Subjects who complete 48 weeks of treatment or who discontinue early but are deemed eligible upon rescreening will be offered participation in the open-label segment of the study and will receive vicriviroc 30 mg once daily if appropriate until commercially available or until the sponsor terminates the clinical development of vicriviroc
This is a randomized double-blind placebo-controlled parallel-group multi-center study of vicriviroc maleate in HIV subjects infected with dualmixed CCR5CXCR4-tropic virus and who have documented resistance to at least 2 of the 3 antiretroviral drug classes NRTI NNRTI or PI or at least 6 months experience with at least 2 of the following one NRTI one NNRTI or one PI excluding low-dose ritonavir and failure on their current stable regimen The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening history of prior antiretroviral drug use by the patient and drug toxicity Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment An interim analysis will be performed when all subjects have completed 24 weeks of treatment Subjects who complete 48 weeks of treatment or who discontinue early but are deemed eligible upon rescreening will be offered participation in the open-label segment of the study and will receive vicriviroc 30 mg once daily if appropriate until commercially available or until the sponsor terminates the clinical development of vicriviroc
Detailed Description:
None
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