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New treatment option for HIV Associated Neurocognitive Disorder
Official title SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
ClinicalTrials.gov ID: NCT05586581
What this study is testing
What is SV2A PET?
SV2A PET is an investigational medicine, being studied as a potential treatment for hiv associated neurocognitive disorder.
Also referred to as [11C]UCB-J, [11C]APP311.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- PLWH
- 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.
You likely can't join if
- Active substance dependence (e.g., heroin, alcohol, cocaine, sedative hypnotics, methamphetamine) as determined by the standardized Behavioral...
- 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...
- Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia...
- History of a bleeding disorder, low platelet count, or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto). HIV -...
- Voluntary, written, informed consent (signed and dated)
See the full eligibility criteria
- PLWH
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.