Clinical trial NCT02144688: COMO: Cognition Study With HIV+ Patients (CTNPT 015)
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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: 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
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: CIHR Canadian HIV Trials Network
First posted: 2014-05-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in neurocognitive functioning over 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
state: Quebec
Study officials:
affiliation: Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)
name: Marie-Josée Brouillette, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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