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RECRUITING
NCT05586581
PHASE1/PHASE2

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

Sponsor: Yale University

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-05-17

Completion Date

2030-12

Last Updated

2025-09-09

Healthy Volunteers

Yes

Interventions

DRUG

SV2A PET

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

DRUG

TSPO 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