Cognitive Symptoms, HIV - Human Immunodeficiency Virus
Conditions
Keywords
Human Immunodeficiency Virus, HIV, Cognitive symptoms, Cognitive evaluation, Neuropsychological testing, Quality of life, Anxiety, Viral load, Antiretroviral, Cerebrospinal fluid, Lumbar puncture, Magnetic resonance imaging, MRI
Brief summary
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.
Interventions
DRUGChange in antiretrovirals
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis
Sponsors
Fonds de la Recherche en Santé du Québec
CIHR Canadian HIV Trials Network
Marie-Josée Brouillette
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neurocognitive functioning over 6 months | 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). |
Countries
Canada
Outcome results
None listed