About The Study

This CTN pilot study will assess 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 is a non-interventional study; no experimental treatment will be 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.

About The Disease

According to study researchers, HIV has a harmful effect on the central nervous system. There is now strong scientific evidence to support that HIV and aging emphasize cognitive decline compared to non-infected persons. 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.

Those most at risk for developing HAND are persons aged 40 years and older who have had a nadir CD4 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

Researchers will use a CANTAB®, a computerized neurocognitive assessment tool, to measure cognitive decline in participants during two clinic visits over one year. The CANTAB, which can be operated by a health worker following minimal training, offers a variety of simple language-free touch screen tests. In the study, the CANTAB® will be compared to a battery of standard neuropsychological tests (lasting 90 minutes) in terms of its sensitivity and specificity.

Eligibility Requirements

Required

HIV positive participants:

  • 40 years or older
  • With a stable HAART regimen for at least the past 6 months
  • Undetectable plasma viral load (at the limit of quantification of assay) for at least 6 months (a single measure of 100 copies/mL is acceptable)
  • Able to communicate adequately in either French or English.

HIV-negative participants (controls):

  • 40 years or older
  • Documented HIV-negative status
  • Willingness to give access to their medical data
  • Able to communicate adequately in either French or English.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Participating Sites

Here’s where this study is being conducted.