Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00988780
Status:
UNKNOWN
Last Update Posted:
2012-11-27
First Post:
2009-10-01
Brief Title:
Maraviroc CCR5 Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
Official Title:
CCR5 Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
CADIRIS
Brief Summary:
The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy
Detailed Description:
This is a randomized double blind placebo-controlled multicenter study testing the utility of a CCR5 antagonist Maraviroc as an adjuvant to a standard HAART regimen to decrease the incidence of Immune Reconstitution Inflammatory Syndrome IRIS in HIV-infected patients naïve to antiretroviral treatment The study duration will be 60 weeks 276 subjects 138 per arm will be recruited The population included will be HIV-infected patients starting antiretroviral ARV therapy at the participating centers in Mexico and South Africa with a CD4 T cell count 100 cellsul Subjects will be randomized to receive either Maraviroc study drug or placebo in addition to background ARV therapy The background antiretroviral regimen for all subjects will be Efavirenz 600mg QD Tenofovir 300 mg Emtricitabine 200 mg QD subjects will be randomized to one of the following arms Arm A background ARV maraviroc 600mg po BID Arm B background ARV placebo po BID Patients will be followed for 48 weeks The primary endpoint will be the occurrence of a defined IRIS event by week 24 of follow up The success of the ARV therapy will also be evaluated by virologic and immunologic response at 24 and 48 weeks Three immunology sub-studies are planned 1 Sub-study A will be conformed by a subgroup of 40 subjects 20 from Mexico and 20 from South Africa additional blood sampling will be performed to evaluate expression of immune activation markers movement of central memory T cells into cell cycle and frequencies of expandable pathogen-reactive CD4 and CD8 T cells in circulation 2 Sub-study B will be conformed by another subgroup of 60 subjects all from South Africa additional blood sampling will be performed to evaluate monocyte and CD4 T cell gene expression as related to activation-induced apoptosis and cytokine secretion 3 Sub-study C will evaluate the incidence of thromboembolic disease in the study patients along with baseline evaluation of possible bio-markers of pro-coagulant state
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