Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00735072
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2008-08-12
Brief Title:
Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV replication with medications Blocking the co-receptor for HIV might decrease inflammation of the immune system potentially providing an immune benefit The goal of the current trial is to determine whether adding maraviroc a new CCR5 co-receptor blocker decreases inflammation providing an immune benefit for patients with low CD4 counts despite undetectable viral loads on HIV medications
In this study HIV-infected patients who are receiving antiretroviral therapy for HIV will receive either maraviroc or a placebo sugar pill each day for 24 weeks After 24 weeks the study medication will be stopped and all subjects will be followed for 12 more weeks Blood tests measuring the extent of inflammation low-level viremia and immune function will be measured throughout the trial and compared between treatment arms
In this study HIV-infected patients who are receiving antiretroviral therapy for HIV will receive either maraviroc or a placebo sugar pill each day for 24 weeks After 24 weeks the study medication will be stopped and all subjects will be followed for 12 more weeks Blood tests measuring the extent of inflammation low-level viremia and immune function will be measured throughout the trial and compared between treatment arms
Detailed Description:
Our primary hypothesis is that CCR5 inhibitors may have protective immunomodulatory effects independent of their impact on HIV replication Specifically we predict that maraviroc will reduce the persistent T cell activation that prevents normal immune reconstitution during HAART-mediated viral suppression This hypothesis will be tested in the context of a placebo controlled pilot study assessing the impact of maraviroc in antiretroviral-treated patients with a CD4 T cell count less than 350 cellsmm3 In order to address the immunologic activity of this drug independent of plasma HIV RNA levels we will study individuals who have undetectable viral loads 75 copies RNAmL Subjects will be randomized to maraviroc for 24 weeks or matching placebo for 24 weeks followed by a 12 week washout period We will use as our primary endpoint the proportion of CD8 T cells that co-expresses CD38 and HLA-DR as these outcomes have been well validated in prior studies The primary outcome will be change in the percentage of activated CD8 T cells at week 24 Change in CD4 T cell counts HIV RNA levels using ultra-sensitive techniques and other more experimental immunologic measurements will be assessed as secondary outcomes
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