Clinical Trial: Maraviroc and NeuroAIDS Pathogenesis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Maraviroc and NeuroAIDS Pathogenesis

Brief 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.

Detailed Summary: 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.
Sponsor: University of Hawaii

Current Primary Outcome: Change in Neuropsychological Performance [ Time Frame: 48 weeks ]

Change in global neuro-psychological Z scores and change in various neuro-psychological Z subdomains will be assessed


Original Primary Outcome: Change in Neuropsychological Performance [ Time Frame: 48 weeks ]

Change in global NPZ scores and change in various NPZ subdomains will be assessed


Current Secondary Outcome:

  • Changes in monocyte subsets and function [ Time Frame: 48 weeks ]
    Change in monocyte subsets based on CD14 and CD16 expression by flow cytometry; Change in inflammatory and neurotoxic mediators (sCD14, TNFalpha, sCD163 and neopterin
  • Change in HIV DNA content within MO subsets [ Time Frame: 48 weeks ]
    Change in HIV DNA content specifically within each MO subsets
  • Change in brain metabolites by magnetic resonance spectroscopy [ Time Frame: 48 weeks ]
    Change in neuronal and inflammatory brain metabolites globally within brain and in select brain regions


Original Secondary Outcome: Same as current

Information By: University of Hawaii

Dates:
Date Received: June 5, 2014
Date Started: May 2015
Date Completion: December 2018
Last Updated: January 3, 2017
Last Verified: January 2017