Treatment Category: Treatment Experienced

ACTG A5324: Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV (INMIND)

Treatment Category: Treatment Experienced

Study Description
A5324 is a randomized, double-blinded, placebo-controlled study for HIV-infected individuals with an undetectable HIV viral load who have at least mild neurocognitive impairment. Participants will be randomized to add either maraviroc plus dolutegravir, dolutegravir alone, or placebo to their current anti-HIV medications.

Study Status

Why is this study being done?

The main purpose of the study is to see if intensification with maraviroc and dolutegravir will improve neurocognitive performance and functioning in persons who have at least mild neurocognitive impairment. Safety and tolerability of maraviroc and dolutegravir when added to a stable HIV regimen and the effect of the study drugs on markers in the blood and spinal fluid will also be studied.

Who can join?

·  HIV-1 infected persons at least 18 years of age

·  On current HIV medications for at least 12 months

·  No prior or current use of any integrase inhibitor or maraviroc

·  HIV viral load less than 50 copies

·  Screening neuropsychological tests showing problems with memory, thinking or daily tasks

What do I need to do in the study?

Neurocognitive tests and questionnaires about daily functioning will be done at screening.

Participants will be randomized (like flipping a coin) to add one of the following regimens to

their current anti-HIV medications for 96 weeks:

Arm A: Placebo for maraviroc and Placebo for dolutegravir

Arm B: Dolutegravir and placebo for maraviroc

Arm C: Maraviroc and Dolutegravir

Neuropsychological testing will be done every 24 weeks.

A subset of participants will have optional spinal taps at entry and week 48.

What treatments or drugs are involved with this study?

The study treatments that will be provided through the study are dolutegravir, maraviroc and/or placebos. Other HIV medications will not be provided by the study.