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

NCT02144688 | Terminated Early Phase 1 DMC

• 1 other identifier: CTNPT 015
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Study Arms (1)

Change in ARVs to improve cognition

EXPERIMENTAL

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

Drug: Change in antiretrovirals

Interventions

Change in antiretrovirals DRUG

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

Change in ARVs to improve cognition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marie-Josée Brouillette: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

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

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (30)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Neurobehavioral Manifestations; Anxiety Disorders

Interventions

Anti-Retroviral Agents

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Marie-Josée Brouillette, MD, FRCPC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2014
• First Posted: May 22, 2014
• Study Start: June 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

CA (1)