Phase 2 HIV and AIDS Trial, Recruiting NCT05586581 Sponsor: Yale University Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT05586581
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people living with HIV (PLWH):

  • People who are willing and able to give written, signed consent to participate
  • Females who have a negative pregnancy test at the screening visit and on each scan day
  • People who have HIV and are on combination antiretroviral therapy (HIV medication), with their virus kept at very low levels for at least one year — meaning no more than one test showed virus levels above 20 copies/mL, and no test showed levels above 200 copies/mL in that time
  • People who are willing to take part in MRI and PET scans, blood draws, and brain/thinking skills tests and surveys

For people without HIV (comparison group):

  • People who are willing and able to give written, signed consent to participate
  • Females who have a negative pregnancy test at the screening visit and on each scan day
  • People who are willing to take part in blood draws, brain/thinking skills tests and surveys, MRI and PET scans
  • People who are in good physical health, as assessed by the lead researcher through medical history, physical and neurological checks, and lab tests
  • People who have a recent negative HIV test on file from the past three months, or who are willing to have an HIV test as part of the study

Who may not be able to join:

For people living with HIV (PLWH):

  • People who are currently dependent on substances such as heroin, alcohol, cocaine, sedatives, or methamphetamine, based on standardised assessments
  • People who have a significant history of neurological conditions unrelated to HIV, such as stroke, seizures, or traumatic brain injury
  • People who have had enough radiation exposure from research or workplace sources in the past year that adding the planned scans would exceed the FDA's annual safety limit for radiation
  • People who have medical reasons they cannot have an MRI scan, such as metal implants or foreign bodies in the body, claustrophobia, a pacemaker, a prosthetic heart valve, or certain ear implants
  • People who have a history of a bleeding disorder, low platelet count, or who are currently taking blood-thinning medications such as Coumadin, Heparin, Pradaxa, or Xarelto

For people without HIV (comparison group):

  • People who are currently dependent on substances such as heroin, alcohol, cocaine, sedatives, or methamphetamine, based on standardised assessments
  • People who have a significant history of neurological conditions such as stroke, seizures, or traumatic brain injury
  • People who have had enough radiation exposure from research or workplace sources in the past year that adding the planned scans would exceed the FDA's annual safety limit for radiation
  • People who have medical reasons they cannot have an MRI scan, such as metal implants or foreign bodies in the body, claustrophobia, a pacemaker, a prosthetic heart valve, or certain ear implants
  • People who have a history of a bleeding disorder or who are currently taking blood-thinning medications such as Coumadin, Heparin, Pradaxa, or Xarelto

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Serena Spudich, MD, Yale University

Phone: (475) 434-4324

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
17 May 2023
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The primary outcome measure for 11C-UCB-J will be the binding potential of 11C-UCB-J, specifically non-displaceable binding potential (BPND), the ratio of the specifically bound radioligand to that of nondisplaceable radioligand in tissue.; Change in cross-sectional differences and 24-month longitudinal changes in synaptic density in PLWH on suppressive ART relative to matched HIV-negative controls

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov