Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474370
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2007-05-15
Brief Title:
Vicriviroc in HIV-Treatment Experienced Subjects Study P04889AM8COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects VICTOR-E4
Status:
COMPLETED
Status Verified Date:
2022-08
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 confirm the previous findings in a larger phase 3 study over a 48-week period and show that when taken in combination with other appropriate HIV drugs vicriviroc can decrease the level of HIV viral load in the blood and that it is well tolerated
Detailed Description:
This is a randomized double-blind placebo-controlled parallel-group multi-center study of vicriviroc maleate in HIV subjects infected with CCR5-tropic virus only 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 two PIs excluding low-dose ritonavirand failed at least one standard triple-drug 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 OBT must include a PI boosted by ritonavir 100 mg of ritonavir and at least 2 active drugs ie to which HIV isolate is fully susceptible 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 After completing Week 48 of the study subjects will be offered open-label vicriviroc 30 mg QD if appropriate until the drug is commercially available or until the sponsor terminates the clinical development of vicriviroc Additionally subjects who discontinued early from the study prior to Week 48 may be eligible for the open-label segment of the study
least 2 of the following one NRTI one NNRTI or two PIs excluding low-dose ritonavirand failed at least one standard triple-drug 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 OBT must include a PI boosted by ritonavir 100 mg of ritonavir and at least 2 active drugs ie to which HIV isolate is fully susceptible 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 After completing Week 48 of the study subjects will be offered open-label vicriviroc 30 mg QD if appropriate until the drug is commercially available or until the sponsor terminates the clinical development of vicriviroc Additionally subjects who discontinued early from the study prior to Week 48 may be eligible for the open-label segment of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-006417-32 | EUDRACT_NUMBER | None | None |
| 3547030 | None | None | None |