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

Launched by YALE UNIVERSITY · Oct 16, 2022

Keywords

ClinConnect Summary

This clinical trial is looking into how HIV affects the brain and how certain brain structures change in people living with HIV who are on treatment. Researchers will use advanced imaging techniques, including PET scans and MRI, to see how the brain's connections (called synapses) might be impacted. The goal is to better understand the relationship between these brain changes and cognitive performance, which refers to how well someone thinks and remembers.

To participate in this study, you need to be between 18 and 74 years old, be living with HIV, and have been on effective treatment for at least a year. Healthy individuals without HIV can also join. Participants will undergo various tests, including imaging scans and memory assessments. It’s important to know that those with certain medical conditions or recent substance use may not be eligible. Overall, this trial aims to gain insights that could help improve the understanding and treatment of HIV-related brain issues.

Gender

ALL

Eligibility criteria

• PLWH Inclusion Criteria:
• • Voluntary, written, informed consent (signed and dated)
• • For females, a negative urine or serum pregnancy (HCG) test at screening and on each scan day before initiation of any scan procedures.
• • 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
• • 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.
• • Willingness to participate in MRI, PET, phlebotomy, and Neuropsychological Testing (NPT) Assessments \& Surveys.
• PLWH Exclusion Criteria:
• • Active substance dependence (e.g., heroin, alcohol, cocaine, sedative hypnotics, methamphetamine) as determined by the standardized Behavioral Assessments.
• • A history of significant non-HIV related neurological illness (e.g., cerebrovascular, seizures, traumatic brain injury).
• • 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).
• • Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.).
• • History of a bleeding disorder, low platelet count, or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
• HIV - Inclusion Criteria:
• • Voluntary, written, informed consent (signed and dated)
• • For females, a negative urine or serum pregnancy (HCG) test at screening and on each scan day before initiation of any scan procedures.
• • Willingness to participate in phlebotomy, NPT Assessments \& Surveys, MRI, and PET.
• • Physically healthy by medical history, physical, neurological, and laboratory examinations, as judged by the principal investigator.
• • Have a negative test for HIV on file within the last three months or willing to have an HIV test in the current study.
• HIV- Exclusion Criteria:
• • Active substance dependence (e.g., heroin, alcohol, cocaine, sedative hypnotics, methamphetamine) as determined by the standardized Behavioral Assessments.
• • A history of significant neurological illness (e.g., cerebrovascular, seizures, traumatic brain injury).
• • 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)
• • Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.
• • History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto