Title | Neurocognition in maraviroc- compared to tenofovir: a double blind randomized placebo controlled trial ACTG A5303. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Robertson KR, Miyahara S, Lee A, Brown TT, Chan ES, Berzins B, Rusin D, Eron JJ, Taiwo BO |
Corporate Authors | ACTG 5303 team |
Journal | AIDS |
Date Published | 2016 Jun 20 |
ISSN | 1473-5571 |
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. |
DOI | 10.1097/QAD.0000000000001189 |
Alternate Journal | AIDS |
PubMed ID | 27333088 |
Grant List | U01 AI068636 / AI / NIAID NIH HHS / United States UM1 AI068636 / AI / NIAID NIH HHS / United States |