Neurocognition in maraviroc- compared to tenofovir: a double blind randomized placebo controlled trial ACTG A5303.

OBJECTIVE: To determine whether maraviroc (MVC) has unique neurocognitive benefits in the context of initial antiretroviral therapy (ART).

DESIGN: Randomized, double-blind, placebo-controlled, 48-week trial.

SETTING: Participants were enrolled in US domestic ACTG clinical trial sites.

PARTICIPANTS: 262 ART naïve, CCR5 tropic HIV, and HIV RNA < 1000 cps/ml participants were randomized, 230 participants completed the study.

INTERVENTION: Participants received MVC 150 mg or tenofovir disoproxil fumarate (TDF) 300 mg on a background of ritonavir-boosted darunavir and emtricitabine.

MAIN OUTCOME MEASURE(S): The neuropsychological (NP) battery of 15 tests done at baseline, week 24 and week 48 assessed 7 domains, and were standardized into z scores then converted into deficit scores (DS) and a global deficit score (GDS). The 48-week changes from baseline in the NP scores and the GDS were compared by Wilcoxon or Kruskal-Wallis test between arms, and among baseline impairment groups (classified as normal, mild (2 DS ≥1) and moderate (2 DS ≥2)). It was hypothesized that the MVC arm would have improved NP performance over TDF.

RESULTS: In this double blind randomized placebo controlled trial, there were no differences in NP between MVC and TDF. Those with moderate NP impairment at baseline experienced greater ART-mediated NP improvement than those with mild or no NP impairment.

CONCLUSIONS: Improvement in neurocognitive functioning was greater with more baseline impairment but was comparable with MVC or TDF.