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

Early Phase 1

Terminated

• Conditions: HIV - Human Immunodeficiency Virus; Cognitive Symptoms
• Interventions: Drug: Change in antiretrovirals

• Registration Number: NCT02144688
• Lead Sponsor: Marie-Josée Brouillette

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-03-29
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-22
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Change in ARVs to improve cognition	Change in antiretrovirals	Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC); 🇨🇦 Montreal, Quebec, Canada