Functional Imaging Reserve in NeuroHIV

NCT ID: NCT03596268

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-20

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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HIV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Imaging

Intervention Type DIAGNOSTIC_TEST

3T Prisma MRI

Serum Laboratory Tests

Intervention Type DIAGNOSTIC_TEST

Blood (plasma and cellular) will be collected.

Lumbar Puncture

Intervention Type DIAGNOSTIC_TEST

CSF will be collected

HIV- Controls

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

Imaging

Intervention Type DIAGNOSTIC_TEST

3T Prisma MRI

Serum Laboratory Tests

Intervention Type DIAGNOSTIC_TEST

Blood (plasma and cellular) will be collected.

Lumbar Puncture

Intervention Type DIAGNOSTIC_TEST

CSF will be collected

Interventions

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Imaging

3T Prisma MRI

Intervention Type DIAGNOSTIC_TEST

Serum Laboratory Tests

Blood (plasma and cellular) will be collected.

Intervention Type DIAGNOSTIC_TEST

Lumbar Puncture

CSF will be collected

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Missouri, St. Louis

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beau M Ances, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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201805047

Identifier Type: -

Identifier Source: org_study_id

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