New brain scans may uncover hidden HIV damage
NCT ID NCT05586581
First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study uses special PET scans to measure brain synapse density in people with HIV who are on effective treatment. Researchers want to understand why some still develop thinking or memory problems. They will compare 70 participants (with and without HIV) over two years using brain imaging and lab tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PET radiotracers ([11C]UCB-J and [11C]PBR28)
- What this could lead to
- If successful, this could reveal why some people with HIV still have brain problems despite treatment, pointing toward future therapies.
- What could go wrong
- This is an early-phase imaging study with only 70 participants, so it won't directly test treatments. Results may not apply to everyone with HIV.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Yale School of Medicne, Neuro ID Research Program
RECRUITINGNew Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a protein powder with creatine and fiber boost everyday Well-Being?
- Green tech or hidden stress? bus Drivers' hearts monitored behind the wheel
- Shout it out: can growls and screams raise pain tolerance?
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Scientists probe why brain stimulation works for some and not others
- Tiny doses, big questions: how does the body handle this prodrug?