Functional Imaging Reserve in NeuroHIV (FIRN)

The Washington University

Status: Completed

Conditions: HIV

Treatments: Diagnostic Test: Serum Laboratory Tests; Diagnostic Test: Lumbar Puncture; Diagnostic Test: Imaging

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03596268

201805047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

284 participants in 2 patient groups

Persons Living with HIV (PLWH)

Description:

Persons 20-80 years old with a documented HIV infection for at least 1 year, who are on a stable cART medication regimen for at least 1 year, and have an undetectable plasma HIV RNA (\<50 copies/ml).

Treatment:

Diagnostic Test: Imaging

Diagnostic Test: Lumbar Puncture

Diagnostic Test: Serum Laboratory Tests

HIV- Controls

Description:

Persons 20-80 years old with confirmed HIV- status matched to PLWH cohort with similar age, sex, education, and race.

Treatment:

Diagnostic Test: Imaging

Diagnostic Test: Lumbar Puncture

Diagnostic Test: Serum Laboratory Tests