NCT02144688

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

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Marie-Josée Brouillette · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV - Human Immunodeficiency Virus
• Cognitive Symptoms

Interventions

Type	Name	Description
DRUG	Change in antiretrovirals	Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-05-22
• Last updated: 2016-03-16

Locations

1 site across 1 country: Canada