A5324 is a study for persons with HIV with undetectable HIV viral load who have mild neurocognitive impairment. Participants will be randomized (like a flip of a coin) to one of three study arms to add either placebo (sugar pill) for maraviroc (MVC) and placebo for dolutegravir (DTG) (Arm A), DTG active drug and placebo for MVC (Arm B), or MVC and DTG active drugs (Arm C) to their existing HIV treatment known as antiretroviral therapy (ART).
Participants will be assessed with neurocognitive tests (test of how well your brain is working) and questionnaires about their daily life functions. There is an option to undergo lumbar punctures (spinal tap to test the fluid that surrounds the brain).
Purpose of this Study:
The main purpose of the study is to see if adding on MVC and/or DTG will improve neurocognitive performance and functioning in participants who have at least mild neurocognitive impairment and have an undetectable viral load. Safety and tolerability of MVC and DTG when added to a stable ART regimen and the effect of the study drugs on markers in the blood and spinal fluid will also be studied.
Requirements to Enter Study:
- Men or women with HIV at least 18 years of age
- On current ART for at least 12 months
- Undetectable HIV viral load (meaning <50 copies/mL on blood testing)
- No more than one viral load test between 50 and 200 copies/mL (only one “blip”) in the past 6 months
- At least mild HIV-associated neurocognitive impairment on neurocognitive tests done at screening
- Able to complete the neuropsychological tests in English
- No medical problem not related to HIV that may cause cognitive impairment
- No current hepatitis C
- No prior or current use of any integrase inhibitor or MVC
- No active syphilis or treatment for syphilis
Participants will be randomized (1:1:1 like a flip of a coin) to add one of the following regimens to their existing
Arm A: placebo for MVC and placebo for DTG
Arm B: DTG and placebo for MVC
Arm C: MVC and DTG
Neuropsychological testing will be done at entry and every 24 weeks.
A subset of participants will have optional lumbar punctures at entry and week 48.
Duration of Study: 96 weeks