title: Neurocognition with maraviroc compared with tenofovir in HIV.
abstract: The objective was to determine whether maraviroc (MVC) has unique neurocognitive benefits in the context of initial antiretroviral therapy (ART).
  
  
  
  Randomized, double-blind, placebo-controlled, 48-week trial.
  
  
  
  Participants were enrolled in US AIDS Clinical Trials Group clinical trial sites.
  
  
  
  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.
  
  
  
  Participants received MVC 150 mg or tenofovir disoproxil fumarate (TDF) 300 mg on a background of ritonavir-boosted darunavir and emtricitabine.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Improvement in neurocognitive functioning was greater with more baseline impairment but was comparable with MVC or TDF.
authors.affiliation: aUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina bHarvard University, Boston, Massachusetts cJohns Hopkins Hospital, Baltimore, Maryland dNorthwestern University, Chicago, Illinois eFrontier Science & Technology, Amherst, New York, USA.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Robertson
authors.forename: Sachiko
authors.initials: S
authors.lastname: Miyahara
authors.forename: Anthony
authors.initials: A
authors.lastname: Lee
authors.forename: Todd T
authors.initials: TT
authors.lastname: Brown
authors.forename: Ellen S
authors.initials: ES
authors.lastname: Chan
authors.forename: Baiba
authors.initials: B
authors.lastname: Berzins
authors.forename: David
authors.initials: D
authors.lastname: Rusin
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Babafemi O
authors.initials: BO
authors.lastname: Taiwo
mesh_terms: D000386:AIDS-Related Complex / Q000188:drug therapy*; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D003071:Cognition; D003510:Cyclohexanes / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D009483:Neuropsychological Tests; D010919:Placebos / Q000008:administration & dosage; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014481:United States
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D010919:Placebos; D014230:Triazoles; D000068698:Tenofovir; D000077592:Maraviroc