NCT02159027

Maraviroc and NeuroAIDS Pathogenesis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Hawaii · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• AIDS Dementia Complex

Interventions

Type	Name	Description
DRUG	Maraviroc	Maraviroc administered twice daily, dosage based on concomitant medication being taken.
DRUG	Placebo	Maraviroc placebo administered twice daily, dosage based on concomitant medication being taken.

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2014-06-09
• Last updated: 2021-08-30

Locations

2 sites across 2 countries: United States, Puerto Rico