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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Missouri, St. Louis | OTHER |
| Temple University | OTHER |
| University of California, San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| HIV- Controls | Persons 20-80 years old with confirmed HIV- status matched to PLWH cohort with similar age, sex, education, and race. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging | Diagnostic Test | 3T Prisma MRI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult persons living with HIV (PLWH) and demographically similar healthy HIV- controls
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| Name | Affiliation | Role |
|---|---|---|
| Beau M Ances, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Data might be shared when the study has closed.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 7, 2026 | |
| Reset | Jun 30, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 12, 2021 | Jul 7, 2021 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 7, 2026 | Jun 30, 2026 |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001706 | Biopsy |
| D013048 | Specimen Handling |
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| OTHER |
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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.
| Serum Laboratory Tests |
| Diagnostic Test |
Blood (plasma and cellular) will be collected. |
|
| Lumbar Puncture | Diagnostic Test | CSF will be collected |
|
| 5 years |
| D019411 |
| Clinical Laboratory Techniques |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |