Functional Imaging Reserve in NeuroHIV

NCT03596268 | Completed DMC

• 1 other identifier: 201805047
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH.

  The investigators will compare the recruitment of compensatory networks between the PLWH and HIV- controls using multiple linear regression. In exploratory analyses the investigators will compare the brain efficiency between PLWH and HIV-, using similar multiple regression models, controlling for confounders. Among PLWH, the investigators will study the association of brain efficiency with neuropsychological performance testing using multiple regression models.

  5 years

Secondary Outcomes (1)

• Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH.

  5 years

Study Arms (2)

Persons Living with HIV (PLWH)

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).

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

HIV- Controls

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

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

Interventions

Imaging DIAGNOSTIC_TEST

3T Prisma MRI

HIV- Controls; Persons Living with HIV (PLWH)

Serum Laboratory Tests DIAGNOSTIC_TEST

Blood (plasma and cellular) will be collected.

HIV- Controls; Persons Living with HIV (PLWH)

Lumbar Puncture DIAGNOSTIC_TEST

CSF will be collected

HIV- Controls; Persons Living with HIV (PLWH)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult persons living with HIV (PLWH) and demographically similar healthy HIV- controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• University of Missouri, St. Louis: collaborator
• Temple University: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma and cellular) and CSF will be obtained for assessment of immune dysfunction (immune activation and exhaustion). Blood and CSF will be stored on ice until centrifuged (within 30 minutes of collection). EDTA-coagulated blood will be used to isolate PBMCs using the standard Ficoll separation method. PBMCs will be frozen at -80C in 90% FBS 10% RPMI for flow cytometry phenotypic analyses. Plasma, CSF and PBMCs will be aliquoted into vials and frozen (-80C) until at least 60 participants have completed their visit, at which time samples will be sent and batch-analyzed by Dr. Burdo.

MeSH Terms

Interventions

Diagnostic Imaging; Spinal Puncture

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Beau M Ances, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 23, 2018
• Study Start: November 20, 2018
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (1)