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

Early Phase 1TerminatedNCT02144688

Marie-Josée Brouillette19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV - Human Immunodeficiency Virus Cognitive Symptoms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 6 months