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Functional Imaging Reserve in NeuroHIV

Functional Imaging Reserve in NeuroHIV

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03596268
Acronym
FIRN
Enrollment
284
Registered
2018-07-23
Start date
2018-11-20
Completion date
2025-04-30
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

DIAGNOSTIC_TESTImaging

3T Prisma MRI

DIAGNOSTIC_TESTSerum Laboratory Tests

Blood (plasma and cellular) will be collected.

DIAGNOSTIC_TESTLumbar Puncture

CSF will be collected

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Missouri, St. Louis
CollaboratorOTHER
Temple University
CollaboratorOTHER
University of California, San Diego
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH.5 yearsThe 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

MeasureTime frameDescription
Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH.5 yearsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026