Maraviroc and NeuroAIDS Pathogenesis

  • STATUS
    Not Recruiting
  • participants needed
    42
  • sponsor
    University of Hawaii
Updated on 22 January 2021
Investigator
Valerie E Wojna, MD
Primary Contact
Puerto Rico Clinical and Translational Research Consortium (6.8 mi away) Contact
+1 other location

Summary

Maraviroc is an antiretroviral medication that may help in improving mental function in HIV infected patients with mental problems by decreasing inflammatory tendencies. We will test this in a clinical trial of 42 HIV infected individuals with some mild to moderate mental problems who are already on HIV medications and doing well. We will add Maraviroc or a sugar pill to their HIV medications and see if mental function improves over 48 weeks. This study will be conducted at 2 sites in Hawaii and Puerto Rico.

Description

We hypothesize that maraviroc (MVC) will lead to improved cognition as assessed by improvement in neuropsychological (NP) performance. We hypothesize that MVC therapy leads to (1) decrease in HIV infection of monocytes (MO), particularly of CD16-expressing MO and (2) phenotypic and functional secretory changes suggestive of decrease in MO immune activation, and that these changes will lead to less HIV infected activated MO trafficking to the CNS, less CNS inflammation and neuronal damage, and ultimately improved cognition. We will test this in a 48 week trial in 42 HIV infected individuals on suppressive antiretroviral therapy (ART) with mild to moderate cognitive dysfunction. These individuals will be randomized to intensify their ART in double-blind fashion to MVC vs placebo. The primary endpoint will be change in NPZglobal. Magnetic resonance spectroscopy (MRS)/magnetic resonance spectroscopic imaging (MRSI) will be conducted to assess potential alterations in inflammatory and neuronal brain chemicals.

Details
Condition AIDS Dementia Complex
Treatment Placebo, Maraviroc
Clinical Study IdentifierNCT02159027
SponsorUniversity of Hawaii
Last Modified on22 January 2021

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