RecruitingPhase 1Phase 2NCT05586581

SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy

PET Imaging of Synaptic Density Combined With Neuroimmunologic Measures to Reveal Mechanisms of HIV Neuropathogenesis During ART

Sponsor

Yale University

Enrollment

70 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

Healthy HIV Associated Neurocognitive Disorder HIV Dementia HIV Encephalitis

Summary

The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers \[11C\]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET \[11C\]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is using advanced brain imaging (PET scans) to understand how HIV affects the brain in people who are on antiretroviral therapy and have an undetectable viral load. Researchers want to know whether silent brain inflammation or nerve damage persists even when the virus is controlled, and whether this explains thinking and memory difficulties some people with HIV experience. **You may be eligible if...** - You are living with HIV and have had an undetectable viral load (below 20 copies/mL) for at least one year on antiretroviral treatment - You are willing to undergo brain PET and MRI scans, blood draws, and cognitive testing - You have a negative pregnancy test if you can become pregnant **You may NOT be eligible if...** - You have active dependence on alcohol, heroin, methamphetamine, cocaine, or sedatives - You have a significant neurological or psychiatric condition - You are unable to undergo MRI or PET scans (e.g., metal implants, claustrophobia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSV2A PET

SV2A PET scan with radiotracer \[11C\]UCB-J for imaging synaptic density in the brain

DRUGTSPO PET

TSPO PET scan with radiotracer \[11C\]PBR28 for imaging of neuroimmune status

Locations(1)

Yale School of Medicne, Neuro ID Research Program

New Haven, Connecticut, United States

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NCT05586581

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