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

TitleNeurocognition in maraviroc- compared to tenofovir: a double blind randomized placebo controlled trial ACTG A5303.
Publication TypeJournal Article
Year of Publication2016
AuthorsRobertson KR, Miyahara S, Lee A, Brown TT, Chan ES, Berzins B, Rusin D, Eron JJ, Taiwo BO
Corporate AuthorsACTG 5303 team
JournalAIDS
Date Published2016 Jun 20
ISSN1473-5571
Abstract

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.

DOI10.1097/QAD.0000000000001189
Alternate JournalAIDS
PubMed ID27333088
Grant ListU01 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI068636 / AI / NIAID NIH HHS / United States