SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
Recruiting
Phase 1Phase 2Interventional Study
HIV Associated Neurocognitive DisorderHIV DementiaHIV EncephalitisHealthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Basic Science
Participants needed
70 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for people with HIV or related brain conditions to study changes in brain cell connections. Participants will undergo brain scans and tests to understand the effects of HIV on the brain during treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have HIV and have been on medication for at least a year.
I have no more than one viral load test above 20 HIV RNA cps/mL in the past year.
I am willing to participate in brain scans and tests.
I am female and have a negative pregnancy test.
I will provide written consent to participate.
I am in good physical health as judged by a doctor.
You may not be able to join if
I have a history of major non-HIV related brain illnesses.
I have active substance dependence.
I have a bleeding disorder or take blood thinners.
I cannot undergo MRI scans due to implants or claustrophobia.
I have had recent radiation exposure that exceeds safety limits.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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).
Trial Locations
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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 yea…
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
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