Neurocognition with maraviroc compared with tenofovir in HIV.
AIDS
; 30(15): 2315-21, 2016 09 24.
Article
in En
| MEDLINE
| ID: mdl-27333088
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 150âmg or tenofovir disoproxil fumarate (TDF) 300âmg 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Triazoles
/
HIV Infections
/
AIDS-Related Complex
/
Cognition
/
Anti-HIV Agents
/
Cyclohexanes
/
Antiretroviral Therapy, Highly Active
/
Tenofovir
Type of study:
Clinical_trials
Limits:
Adult
/
Female
/
Humans
/
Male
Country/Region as subject:
America do norte
Language:
En
Journal:
AIDS
Journal subject:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Year:
2016
Document type:
Article
Affiliation country:
Estados Unidos