About The Study

This CTN pilot study assessed changes in neurocognitive functioning — the ability to think and reason — over one year in individuals at risk for neurocognitive decline despite virologic suppression of HIV. This was a non-interventional study; no experimental treatment was administered. Results of this pilot study may generate important data for future clinical trials aimed at maintaining or improving cognitive functioning in at-risk individuals.

Background

According to study researchers, HIV can have a harmful effect on the central nervous system. HIV increases age-related cognitive decline compared to people without HIV. Despite having viral suppression and an undetectable plasma viral load, a person may still develop HIV-associated neurocognitive disorder (HAND).

Mild forms of neurocognitive decline may include problems with memory, language, thinking and judgment; though these minor “slips” are generally not severe enough to interfere with day-to-day activities.

Among aviremic individuals, those considered most at risk for developing HAND are persons aged 40 years and older who have had a CD4 count below 200. In addition to these criteria, to be enrolled in the study, subjects have to have been on a stable ART regimen for at least six months and have an undetectable viral load over the last six months.

Study Approach

Between June 2012 and May 2013, 50 clinically stable people living with HIV and 17 matched HIV-negative individuals were recruited. Participants were administered a neuropsychological test battery on two occasions, one year apart. Several algorithms for HAND classification were applied. Change in overall cognition over one year was measured by the NPZ.

Principal Investigators

Here’s who is leading this study.

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