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SV2A & TSPO PET Imaging for HIV Neurocognitive Disorders (ART Trial)

Phase 1 & 2
Recruiting
Led By Serena Spudich, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion date, an average of 5 years.
Awards & highlights

ART Trial Summary

This trial will study how HIV affects the brain's synaptic density using advanced brain scans and clinical tests.

Who is the study for?
This trial is for adults with well-controlled HIV on antiretroviral therapy (ART) for at least a year, showing minimal viral presence in tests. Participants must consent to the study and women must test negative for pregnancy. It's not suitable for those who can't undergo MRI or PET scans, blood draws, or neuropsychological assessments.Check my eligibility
What is being tested?
The study uses advanced PET imaging with [11C]UCB-J and [11C]PBR28 tracers to measure synaptic density and microglia function in the brain of HIV patients on ART. It aims to understand changes in brain structure related to HIV injury by correlating these measures with neurocognitive performance and lab results.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include discomfort from lying still during imaging procedures, exposure to radiation from PET scans, potential allergic reactions to tracers used in imaging studies, and anxiety or discomfort from undergoing neurological assessments.

ART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion date, an average of 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion date, an average of 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cross-sectional differences and 24-month longitudinal changes in synaptic density in PLWH on suppressive ART relative to matched HIV-negative controls
The 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.

ART Trial Design

2Treatment groups
Experimental Treatment
Group I: People living with treated suppressed HIV infection (PLWH)Experimental Treatment2 Interventions
40 PLWH participants will be scanned using anatomical magnetic resonance imaging (MRI) and undergo two SV2A (11C-UCB-J) PET scans with arterial sampling and full radio metabolite analysis to obtain measures of synaptic density at baseline and 24 months (2 years). For each SV2A PET, up to 20 millicurie (mCi) of [11C], UCB-J will be administered by an intravenous line (IV) with a scan duration of up to 120 minutes. A subset of PLWH (n=20) will participate in TSPO (11C-PBR28) PET scans on the same day as the baseline SV2A PET scan. For a TSPO PET, up to 20 mCi of [11C], PBR28 will be administered by an intravenous line (IV) with a scan duration of up to 120 minutes.
Group II: HIV-Negative Control (HIV-)Experimental Treatment1 Intervention
30 HIV-Negative Control (HIV-) participants will be scanned using anatomical magnetic resonance imaging (MRI) and undergo two SV2A (11C-UCB-J) PET scans with arterial sampling and full radio metabolite analysis to obtain measures of synaptic density at baseline and 24 months (2 years). For each SV2A PET, up to 20 mCi of [11C], UCB-J will be administered by an intravenous line (IV) with a scan duration of up to 120 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TSPO PET
2021
N/A
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
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National Institutes of Health (NIH)NIH
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Media Library

People living with treated suppressed HIV infection (PLWH) Clinical Trial Eligibility Overview. Trial Name: NCT05586581 — Phase 1 & 2
Dementia Research Study Groups: People living with treated suppressed HIV infection (PLWH), HIV-Negative Control (HIV-)
Dementia Clinical Trial 2023: People living with treated suppressed HIV infection (PLWH) Highlights & Side Effects. Trial Name: NCT05586581 — Phase 1 & 2
People living with treated suppressed HIV infection (PLWH) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05586581 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria are used to determine eligibility for this clinical trial?

"This dementia research trial is recruiting 70 people aged 18 to 80 years old. The participation criteria necessitate that participants have already been diagnosed with the condition."

Answered by AI

Are researchers currently accepting participants for this research endeavor?

"According to the clinicaltrials.gov database, this trial is still recruiting patients and has been running since May 17th 2023 with recent updates as of June 26th 2023."

Answered by AI

What is the highest capacity of participants in this research endeavor?

"Affirmative, the clinicaltrials.gov database reveals that this medical trial is currently in search of enrollment from patients. It was initially posted on May 17th 2023 and updated most recently on June 26th 2023; 70 participants are needed at a single research site."

Answered by AI

Does this experiment offer participation to individuals of advanced age?

"According to the guidelines, potential participants must be aged at least 18 and no more than 80 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
Serena Spudich, MD 2023. "SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05586581.
~47 spots leftby Dec 2027
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