This is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding maraviroc (MVC) and dolutegravir (DTG) to the current antiretroviral therapy (ART) of HIV-infected individuals who have at least mild neurocognitive impairment with a primary outcome of improvement in neurocognitive performance.
Purpose of This Study:
Objectives of this study are:
To assess the safety and tolerability of MVC and DTG when added to a stable ART regimen;
To determine if intensification with MVC and DTG, or DTG alone, will improve neurocognitive functioning at week 48 in subjects who have at least mild neurocognitive impairment;
To determine the effect of MVC and/or DTG, on biomarkers in the blood and CSF
Requirements to Enter study:
- HIV+ adults, age 18+
- On current ART >12 mos, with no plans to change while on study; no prior or current use of MVC or any integrase inhibitor; no current use of nevirapine, tripranavir, fosampranavir.
- HIV-1 RNA <50 copies/mL within 90 days prior to study entry; only one ‘blip’ <200 copies/mL
- allowed in the past 6 months.
- HAND diagnosis (ANI, MND, or HAD) determined at screening clinical visit.
- Women of reproductive potential at least one reliable method of contraception throughout study.
- No current or past medical condition(s) that in the opinion of the investigator prevents attribution of
- cognitive impairment to HIV. Examples: major depressive disorder with psychotic features;
- traumatic brain injury; mental retardation/severe educational disability; ongoing substance use
- disorder with significant impact on daily living activities; CNS infections/conditions.
- No known untreated B12 deficiency or malnutrition
- No Hepatitis C virus seropositive/unstable and advanced liver disease
- No presence of an AIDS-defining opportunistic infection within 180 days
- No active syphilis or treatment for syphilis within 90 days
Randomized (1:1:1) at entry to:
- 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.
Duration of Study:
Subjects will participate in this study for 96 weeks. There are 10 clinic visits, including screening and pre-entry visits. Compensation and parking/bus tickets provided. Travel reimbursement expenses are provided.