Clinical trial NCT03596268: Functional Imaging Reserve in NeuroHIV
Official title: Functional Imaging Reserve in NeuroHIV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Missouri, St. Louis
name: Temple University
name: University of California, San Diego
First posted: 2018-07-23
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult persons living with HIV (PLWH) and demographically similar healthy HIV- controls

Brief summary: The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. Results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in PLWH who have impaired neuropsychological performance.

Detailed description: This proposal systematically characterizes brain efficiency and recruitment in virologically suppressed persons living with HIV (PLWH) and demographically similar HIV uninfected (HIV-) controls. This proposal collects advanced functional neuroimaging that provide critical information about cerebral blood flow (CBF) and brain connectivity (functional connectivity strength; FCS); quantitative measures of immune dysfunction in the blood and cerebrospinal fluid (CSF) (immune activation and immune exhaustion); and neuropsychological performance testing. This overall goal of this proposal is to delineate the interplay between dysfunction in frontal networks and recruitment of compensatory networks that underlie the neuropsychiatric symptoms seen in PLWH.

Eligibility criteria: Inclusion Criteria:

* 20 to 80 years old
* documented HIV infection for at least 1 year or confirmed HIV - status
* PLWH must be on stable cART regimen for at least 12 months with undetectable plasma HIV RNA (less than 50 copies per mL)
* at least 9 years of education
* able to provide informed consent
* if female, a negative pregnancy test and not breast feeding
* able to undergo an MRI scan

Exclusion Criteria:

* significant neurological disorders (e.g. stroke, head injury with loss of consciousness for more than 5 minutes, developmental learning disability)
* active uncontrolled Axis I psychiatric disorder according to the DSM 5
* current or history of substance use disorder (including, but not limited to amphetamines, cocaine, alcohol, opiates, and barbiturates)
* prescribed blood thinners
* allergic to lidocaine or similar anesthetic
* history of any bleeding disorder
* contraindication to MRI scanning (e.g. claustrophobia, pacemaker, etc.)
* pregnant or breastfeeding

Primary outcomes:
measure: Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH.
timeFrame: 5 years
Secondary outcomes:
measure: Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH.
timeFrame: 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Beau M Ances, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: