Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345630
Status:
TERMINATED
Last Update Posted:
2016-01-14
First Post:
2011-04-27
Brief Title:
Comparative Trial Of Maraviroc Versus EmtricitabineTenofovir Both With DarunavirRitonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Comparative Trial Of Maraviroc DarunavirRitonavir Versus EmtricitabineTenofovir DarunavirRitonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MODERN
Brief Summary:
The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabinetenofovir also administered once daily each in combination with darunavirritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment
Detailed Description:
The study was terminated on October 8 2013 following a preliminary review of the Week 48 primary efficacy data by the studys external independent Data Monitoring Committee DMC The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm EmtricitabineTenofovir
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 |
|---|---|---|---|
| 2010-021785-30 | EUDRACT_NUMBER | None | None |