Neurocognition with maraviroc compared with tenofovir in HIV

AIDS. 2016 Sep 24;30(15):2315-21. doi: 10.1097/QAD.0000000000001189.

Abstract

Objective: The objective was 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 AIDS Clinical Trials Group clinical trial sites.

Participants: Total 262 ART-naive, chemokine coreceptor 5 tropic HIV, and HIV RNA greater than 1000 copies/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 battery of 15 tests done at baseline, week 24 and week 48 assessed seven domains, and were standardized into z-scores then converted into deficit scores and a global deficit score. The 48-week changes from baseline in the neuropsychological scores and the global deficit score were compared by Wilcoxon or Kruskal-Wallis test between arms, and among baseline impairment groups [classified as normal, mild (2 deficit scores ≥1) and moderate (2 deficit scores ≥2)]. It was hypothesized that the MVC arm would have improved neuropsychological performance over TDF.

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

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

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • AIDS-Related Complex / drug therapy*
  • Adult
  • Anti-HIV Agents / therapeutic use*
  • Antiretroviral Therapy, Highly Active / methods*
  • Cognition*
  • Cyclohexanes / therapeutic use*
  • Double-Blind Method
  • Female
  • HIV Infections / drug therapy*
  • Humans
  • Male
  • Maraviroc
  • Neuropsychological Tests
  • Placebos / administration & dosage
  • Tenofovir / therapeutic use*
  • Treatment Outcome
  • Triazoles / therapeutic use*
  • United States

Substances

  • Anti-HIV Agents
  • Cyclohexanes
  • Placebos
  • Triazoles
  • Tenofovir
  • Maraviroc