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

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ClinicalTrials.gov Identifier: NCT02144688
Recruitment Status : Terminated (In 14 participants who had LP, very low level viremia was found in only 1)
First Posted : May 22, 2014
Last Update Posted : March 16, 2016
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

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.

Condition or disease Intervention/treatment Phase
HIV - Human Immunodeficiency Virus Cognitive Symptoms Drug: Change in antiretrovirals Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Changes in neurocognitive functioning over 6 months [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144688


Locations
Canada, Quebec
Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H2X 2P4
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)

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
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marie-Josée Brouillette, 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:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Neurobehavioral Manifestations
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms