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Completed

NCT Number: NCT03596268

Functional Imaging Reserve in NeuroHIV

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.

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Key information

Conditions

HIV

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging

Diagnostic Test

3T Prisma MRI

Serum Laboratory Tests

Diagnostic Test

Blood (plasma and cellular) will be collected.

Lumbar puncture

Diagnostic Test

CSF will be collected

Primary outcomes

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

    Time frame: 5 years

    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.

Secondary outcomes

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

    Time frame: 5 years

    The investigators will compare the recruitment (response) between the four HIV age groups (HIV- <50 year old, HIV- ≥50 years old, HIV+ <50 years old, and HIV+ ≥50 years old) using a multiple regression (ANCOVA) model, adjusting for potential confounders (age, sex, education, past substance use, and CVD). The pairwise comparisons of primary interest is between the HIV- <50 years old and the HIV- ≥50 years old groups. Among the PLWH only, the investigators will compare the brain efficiency r (response) between the younger and older group using multiple regression, adjusting for potential confounders. Secondly, a mediation analysis will examine the role of immune dysfunction (activation and exhaustion) markers as mediators of this relationship.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institutes of Health (NIH)
  • Temple University
  • University of California, San Diego
  • University of Missouri, St. Louis

Registry information

Acronym: FIRN

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2018
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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