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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by McGill University Health Center
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Marie-Josée Brouillette, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT02144688
First received: March 29, 2014
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV - Human Immunodeficiency Virus
Cognitive Symptoms
Drug: Change in antiretrovirals
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Changes in neurocognitive functioning over 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Change in ARVs to improve cognition
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis
Drug: Change in antiretrovirals
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02144688

Contacts
Contact: Nathalie Paisible +1 514-934-1934 nathalie.paisible@muhc.mcgill.ca

Locations
Canada, Quebec
Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC) Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Marie-Josée Brouillette, MD    +1 514 843-2090    marie-josee.brouillette@muhc.mcgill.ca   
Contact: Nathalie Paisible    +1 514-934-1934    nathalie.paisible@muhc.mcgill.ca   
Principal Investigator: Marie-Josée Brouillette, MD         
Sponsors and Collaborators
Marie-Josée Brouillette
Fonds de la Recherche en Santé du Québec
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Marie-Josée Brouillette, MD, FRCPC Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
  More Information

Additional Information:
Publications:

Responsible Party: Marie-Josée Brouillette, Associate Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02144688     History of Changes
Obsolete Identifiers: NCT01848678
Other Study ID Numbers: CTNPT 015
Study First Received: March 29, 2014
Last Updated: May 30, 2014
Health Authority: Canada: Health Canada
Canada: Public Health Agency of Canada

Keywords provided by McGill University Health Center:
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Neurobehavioral Manifestations
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014