Ignite Creation Date:
2024-05-05 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00551018
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2007-10-29
Brief Title:
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects Study P04875
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects
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 smaller studies in HIV treatment-experienced patients have shown that vicriviroc is safe and effective The purpose of this study is to evaluate the virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz in HIV-infected treatment-naïve subjects
Detailed Description:
This is a randomized open-label active-controlled parallel-group multi-center study of vicriviroc maleate in treatment-naïve subjects infected with CCR5-tropic HIV The study will compare the virologic benefit of vicriviroc combined with ritonavir-boosted Reyataz to a control group receiving Truvada plus ritonavir-boosted Reyataz Interim analyses will be performed when the first cohort of 80 subjects have completed 24 weeks and 48 weeks of treatment The second cohort of 120 subjects will be enrolled after the first interim analysis a third interim analysis will be performed when subjects in this second cohort have completed 24 weeks of treatment The primary efficacy analysis will be conducted when all 200 subjects from both stages have completed 48 weeks of treatment or discontinued The final analysis will be performed at Week 96 when all 200 subjects have completed 96 weeks of treatment or discontinued If vicriviroc is shown to provide benefit at the studied dose study participants in the vicriviroc arm who complete 96 weeks of treatment may continue in a protocol extension where they will be offered vicriviroc free of charge until the drug is commercially available in their location or until the sponsor terminates the clinical development of vicriviroc
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