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

NCT02144688 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-03-16

No results posted yet for this study

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

DRUG

Change in antiretrovirals

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

Sponsors & Collaborators

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • Marie-Josée Brouillette

    lead OTHER

Principal Investigators

  • Marie-Josée Brouillette, MD, FRCPC · Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144688 on ClinicalTrials.gov