Trial record 2 of 33 for:    " April 03, 2013":" May 03, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by CIHR Canadian HIV Trials Network
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
CIHR Canadian HIV Trials Network
ClinicalTrials.gov Identifier:
NCT01848678
First received: May 3, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

The purpose of this study is to describe the clinical characteristics of HIV+ individuals assessed for cognitive difficulties following the implementation of a step-wise investigation that includes CSF analysis as a standard of care for HIV+ individuals with cognitive symptoms. This study will also assess changes in neurocognitive functioning over 6 months following the implementation of a change in ARV following the investigation. Finally, it will evaluate the capacity of a brief tool to measure cognition in tracking cognitive change over time.


Condition Intervention Phase
HIV - Human Immunodeficiency Virus
Cognitive Symptoms
Other: Evaluation of the need of a change in ARVs and implementation of the change
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CTNPT 015 - Pilot Project to Implement a Step-wise Investigation That Includes CSF Analysis as a Standard of Care for HIV+ Individuals With Cognitive Symptoms.

Resource links provided by NLM:


Further study details as provided by CIHR Canadian HIV Trials Network:

Primary Outcome Measures:
  • Changes in neurocognitive functioning over 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    1. To describe the clinical characteristics of HIV+ individuals assessed for cognitive difficulties following the implementation of a step-wise approach that includes CSF analysis.
    2. To assess changes in neurocognitive functioning over 6 months following the implementation of the treatment recommendations that resulted from the investigation


Secondary Outcome Measures:
  • Capacity of a brief tool to measure cognition in tracking cognitive change over time [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25 HIV+ patients with unexplained cognitive decline Other: Evaluation of the need of a change in ARVs and implementation of the change
Once the clinical investigation and the cognitive assessment have been completed, the research team will evaluate whether a change in ARVs is warranted and implement it if indicated.

  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 HAART 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- MSK stage 3 or more (see Appendix 1)
  • past history of CNS 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: NCT01848678

Contacts
Contact: Marie-Josee Brouillette, MD, Psychiatrist +1 514-843-2090 marie-josee.brouillette@muhc.mcgill.ca
Contact: Melissa Campagnolo +1 514 934-1934 ext 31353 campagnolo.melissa@gmail.com

Locations
Canada, Quebec
Montreal Chest Institute (MCI) - Chronic Viral Illness Service - McGill University Health Center (MUHC) Recruiting
Montreal, Quebec, Canada, H2X2P4
Contact: Marie-Josee Brouillette, MD, Psychiatrist    +1 514-843-2090    marie-josee.brouillette@muhc.mcgill.ca   
Contact: Melissa Campagnolo    +1 514 934-1934    campagnolo.melissa@gmail.com   
Principal Investigator: Marie-Josee Brouillette, MD, Psychiatrist         
Notre-Dame Hospital - Unité hospitalière de recherche, d'enseignement et de soins sur le sida (UHRESS) - Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montreal, Quebec, Canada, H2L 2W5
Contact: Marie-Josee Brouillette, MD, Psychiatrist    +1 514-843-2090    marie-josee.brouillette@muhc.mcgill.ca   
Principal Investigator: Marie-Josee Brouillette, MD, Psychiatrist         
Sponsors and Collaborators
CIHR Canadian HIV Trials Network
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Marie-Josee Brouillette, MD, Psychiatrist Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
  More Information

Additional Information:
Publications:

Responsible Party: CIHR Canadian HIV Trials Network
ClinicalTrials.gov Identifier: NCT01848678     History of Changes
Other Study ID Numbers: CTNPT 015
Study First Received: May 3, 2013
Last Updated: May 3, 2013
Health Authority: Canada: Health Canada
Canada: Research Institute of the McGill University Health Centre
Canada: The CTN CIHR Canadian HIV Trials Network

Keywords provided by CIHR Canadian HIV Trials Network:
Human Immunodeficiency Virus
Cognitive Symptoms
Cognitive evaluation
Neuropsychological testing
Quality of life
Anxiety
Viral load
Antiretroviral
Cerebrospinal fluid
Lumbar puncture
Magnetic Resonance Imaging

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 July 20, 2014