COMO: Cognition Study With HIV+ Patients (CTNPT 015)

Study Overview
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Brief Summary
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The purpose of this study is to contribute evidence towards the potential to improve cognition in HIV+ individuals experiencing cognitive decline through personalized change in antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to identify confounding clinical conditions, study participants will undergo a lumbar puncture to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition will be measured in all at study entry and 6 months later.

Official Title
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CTNPT 015 - Pilot Project to Implement a Step-wise Investigation That Includes Cerebrospinal (CSF) Analysis as a Standard of Care for HIV+ Individuals With Cognitive Symptoms

Conditions
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HIV - Human Immunodeficiency Virus, Cognitive Symptoms

Intervention / Treatment
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* Drug: Change in antiretrovirals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are 18 years and older have 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 ART regimen for > 6 months have an undetectable viral load in plasma for at least 6 months (a single blip of ≤ 150 copies/mL will be accepted) have not had a change in medications that could potentially interfere with cognition in the past 4 months Exclusion Criteria: detectable VL in the plasma past history of dementia past history of Central Nervous System opportunistic infection or stroke current substance abuse ( as per DSM-IV criteria) other than cigarettes coagulopathy thrombocytopenia use of Coumadin intra-cranial hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Change in ARVs to improve cognition<br>Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis | Drug: Change in antiretrovirals<br>* Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in neurocognitive functioning over 6 months | Cognition will be assessed at study entry and 6 months with the following tests: Letter Fluency, Category Fluency, Letter-Number Sequencing, Digit-Symbol, Symbol Search, Grooved Pegboard, Hopkins Verbal Learning Test-Revised, Stroop, Brief Visuospatial Memory Test-Revised, Tower of London, Trail Making Test A and B, Spatial Span, Montreal Cognitive Assessment (MoCA), and a brief computerized battery of tests (B-CAM). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive evaluation, Neuropsychological testing, Quality of life, Anxiety, Viral load, Antiretroviral, MRI, Human Immunodeficiency Virus, HIV, Cognitive symptoms, Cerebrospinal fluid, Lumbar puncture, Magnetic resonance imaging