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

Primary Purpose

HIV - Human Immunodeficiency Virus, Cognitive Symptoms

Status
Terminated
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Change in antiretrovirals
Sponsored by
Marie-Josée Brouillette
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV - Human Immunodeficiency Virus focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Change in ARVs to improve cognition

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 29, 2014
Last Updated
March 15, 2016
Sponsor
Marie-Josée Brouillette
Collaborators
Fonds de la Recherche en Santé du Québec, CIHR Canadian HIV Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT02144688
Brief Title
COMO: Cognition Study With HIV+ Patients (CTNPT 015)
Acronym
COMO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
In 14 participants who had LP, very low level viremia was found in only 1
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marie-Josée Brouillette
Collaborators
Fonds de la Recherche en Santé du Québec, CIHR Canadian HIV Trials Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV - Human Immunodeficiency Virus, Cognitive Symptoms
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Change in ARVs to improve cognition
Arm Type
Experimental
Arm Description
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis
Intervention Type
Drug
Intervention Name(s)
Change in antiretrovirals
Intervention Description
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis
Primary Outcome Measure Information:
Title
Changes in neurocognitive functioning over 6 months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Josée Brouillette, MD, FRCPC
Organizational Affiliation
Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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COMO: Cognition Study With HIV+ Patients (CTNPT 015)

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