RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-05-17
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05586581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Voluntary, written, informed consent (signed and dated)
  2. * For females, a negative urine or serum pregnancy (HCG) test at screening and on each scan day before initiation of any scan procedures.
  3. * HIV infection on cART with documented viral suppression for at least one year. Plasma viral suppression will be defined as no more than one viral load
  4. * Test above 20 HIV RNA cps/mL in the year prior to screening and no HIV RNA tests above 200 cps/mL in the same span.
  5. * Willingness to participate in MRI, PET, phlebotomy, and Neuropsychological Testing (NPT) Assessments \& Surveys.
  1. * Active substance dependence (e.g., heroin, alcohol, cocaine, sedative hypnotics, methamphetamine) as determined by the standardized Behavioral Assessments.
  2. * A history of significant non-HIV related neurological illness (e.g., cerebrovascular, seizures, traumatic brain injury).
  3. * Medical contraindications to the administration of radioactivity (e.g., prior radiation exposure within the past year from research, or from workplace exposure, that in combination with the planned scans would exceed the FDA limit for annual radiation exposure).
  4. * Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.).
  5. * History of a bleeding disorder, low platelet count, or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).

Contacts and Locations

Study Contact

Alliosn Nelson, RN
CONTACT
(475) 434-4324
allison.nelson@yale.edu

Principal Investigator

Serena Spudich, MD
PRINCIPAL_INVESTIGATOR
Yale School of Medicine

Study Locations (Sites)

Yale School of Medicne, Neuro ID Research Program
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Serena Spudich, MD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-17
Study Completion Date2030-12

Study Record Updates

Study Start Date2023-05-17
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • Human immunodeficiency virus
  • Positron-Emission Tomography Imaging
  • Magnetic Resonance Imaging
  • Cerebrospinal Fluid
  • SV2A PET
  • TSPO PET
  • Neuro-immune dysfunction
  • Neuro-Inflammation
  • Biomarkers of inflammation
  • Neuronal Injury
  • Neurocognitive functioning
  • Hippocampus
  • Microglia
  • Neuropathogenesis
  • antiretroviral therapy

Additional Relevant MeSH Terms

  • HIV Associated Neurocognitive Disorder
  • HIV Dementia
  • HIV Encephalitis
  • Healthy