Actively Recruiting
SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
Led by Yale University · Updated on 2025-09-09
70
Participants Needed
1
Research Sites
393 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Voluntary, written, informed consent
- For females, negative pregnancy test at screening and before each scan day
- For PLWH: HIV infection on ART with documented viral suppression for at least one year
- Willingness to participate in MRI, PET, blood draws, and neuropsychological testing
- For HIV-negative: confirmed negative HIV test within last three months or willing to test
- Physically healthy as judged by medical history and examinations
You will not qualify if you...
- Active substance dependence (e.g., heroin, alcohol, cocaine, sedatives, methamphetamine)
- History of significant non-HIV neurological illness (e.g., stroke, seizures, traumatic brain injury)
- Medical contraindications to radioactivity exposure exceeding FDA limits
- Medical contraindications to MRI (e.g., ferromagnetic implants, claustrophobia, pacemaker)
- History of bleeding disorders or current use of anticoagulant medications such as Coumadin, Heparin, Pradaxa, or Xarelto
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale School of Medicne, Neuro ID Research Program
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
A
Allison Nelson, RN
CONTACT
P
Paige Ryall
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here