About The Study

This interventional study will enroll people living with HIV who are experiencing cognitive decline. Participants will receive a comprehensive medical, psychiatric and neurological evaluation followed by Cerebrospinal Fluid analysis used to document HIV viral presence and genotype, and Antiretroviral drug (ARV) concentrations in the Central Nervous System. A change in prescribed ARV treatment will follow, if indicated based on these analyses. Cognition will be documented with neuropsychological testing and a computerized battery at baseline and 6 months, whether or not ARVs have been changed. The purpose of this study is to describe the clinical characteristics of HIV+ individuals assessed for cognitive difficulties, assess changes in neurocognitive functioning over six months following the implementation of a change in ARV’s and evaluate the capacity of a brief tool to measure cognition in tracking cognitive change over time.

About The Disease

There is evidence linking the presence of HIV in the Central Nervous System (CNS) with decreased cognitive function. As the virus cannot be measured directly in the brain tissue, Cerebrospinal Fluid (CSF) levels are often used as a surrogate marker for measuring viral presence in the brain. Some researchers have found evidence that CSF viral load decline is correlated with improvement in neuropsychological performance in people living with HIV who have symptoms of cognitive impairment. People suffering cognitive impairment who initiate highly active antiretroviral therapy (HAART) and attain CSF viral suppression demonstrate greater improvement in cognition than those in whom CSF virus remains detectable despite HAART.

Study Approach

The researchers will use both standard neuropsychological testing and questionnaires, as well as a computerized battery for assessment of cognition. The questionnaires and standard neuropsychological tests will be administered in French or English depending on the participants’ first language. In order to make sure that there is no condition other than HIV itself that can explain the cognitive decline, the patients will first undergo a complete examination by an HIV physician knowledgeable about cognition, a neurologist, a psychiatrist, and a pharmacist specialized in HIV. Participants will also be asked to have a lumbar puncture in order to measure HIV viral load in the Cerebrospinal Fluid. Treatment recommendations will be made and participants will be followed for six months. The study will recruit up to 50 people living with HIV to enter the initial phase of investigation. Twenty-five of those participants will be selected for the study based on an extensive investigation and willingness to have a lumbar puncture for the measurement of HIV in the Cerebrospinal Fluid.

Eligibility Requirements

Required

  • Are 18 years and olderhave the capacity to give informed consent as determined by the research nurse
  • Have unexplained cognitive decline (reported either by the patient or an outside informant)
  • Have been on a stable HAART regimen for more than 6 months
  • Have an undetectable viral load in plasma for at least 6 months (a single blip of of less than 150 copies/mL will be accepted)
  • Have not had a change in medications that could potentially interfere with cognition in the past 4 months

Not Allowed

  • Detectable viral load in the plasma
  • Past history of dementia
  • Past history of Central Nervous System opportunistic infection or stroke
  • Current substance abuse other than cigarettes
  • Coagulopathy
  • Thrombocytopenia
  • Use of Coumadin
  • Intra-cranial hypertension

Additional Information

If you would like more information about this study please contact a participating site.

Principal Investigator

Here’s who is leading this study.

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

Participating Sites

Here’s where this study is being conducted.

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