drugset / Trial / NCT00735072

Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure

NCT00735072

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-09
Primary completion
2010-04
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Maraviroc Other / unclassified 150 mg Oral
Subject Maraviroc Other / unclassified 300 mg Oral
Subject Maraviroc Other / unclassified 600 mg Oral