Randomized trial of central nervous system-targeted antiretrovirals for HIV-associated neurocognitive disorder.

ABSTRACT:

Background

Antiretroviral (ARV) medications differentially penetrate across the blood-brain barrier into central nervous system (CNS) tissues, potentially influencing their effectiveness in treating brain infection.

Methods

This randomized controlled clinical trial (RCT) called for 120 participants at 5 study sites to be randomized 1:1 to CNS-targeted (CNS-T) or non-CNS-T ART. Entry clinical factors such as ARV experience were balanced across arms using an adaptive randomization approach. The primary outcome, change in neurocognitive performance, was measured as the difference in global deficit score (GDS) from baseline to week 16.

Results

The study was terminated early on the recommendation of its data safety monitoring board on the basis of slow accrual and a low li

SUBMITTER: Ellis RJ 

PROVIDER: S-EPMC3952601 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature