FNOS in HIV Subjects

• Status: Recruiting
• Trial end date: 2024-12-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT).

Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting at approximately the time of injection of [18F]NOS.

Participants are required to have a brain MRI performed within 1 year prior to study enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for this study they will be asked to undergo a research brain MRI after they have consented for this study.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania

Criteria

Inclusion Criteria:

1. 18-60 years of age

2. Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

3. Opioid Use Disorder (OUD) status will be defined as the following (to determine which cohort to be enrolled in):

OUD positive (+): Participants will meet DSM-5 criteria for current OUD and will be on a stable dosage of OUD treatment for at least four weeks prior to the screening visit.

OUD negative (-): Must have never met DSM-5 criteria for OUD and not used an opioid for any reason in the 30 days prior to screening by self-report, medical record review, and urine drug testing at screening.

4. HIV status will be defined as the following (to determine which cohort subjects will be enrolled in):

HIV positive (+): Diagnosed with HIV-1 infection per medical record review. Requirements for study participation for HIV+ participants:

• On stable ART regimen (no changes to treatment within 4 weeks of the Screening visit)

• Viral load of less than or equal to 200 cells/mm3 within 12 months of screening (per medical record review)

• CD4+ count greater than 200 cells/mm3 within 12 months of screening (per medical record review)

HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test at screening.

Exclusion Criteria:

5. Women who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential within one day of the PET/CT scan.

6. At screening, the participant's weight is > 350 lb.

7. Subjects who report claustrophobia, which in the opinion of an investigator would interfere with acquisition of the structural MRI required for PET co-registration, and/or the PET scan itself.

8. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible). An MRI screening form will be completed during screening.

9. Screening lab values that indicate significant organ dysfunction that in the opinion of an investigator could compromise participant safety or successful participation in the study.

10. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report

11. History of head trauma that in the opinion of an investigator may interfere with the uptake of applicable radiotracer as assessed by medical record review and/or self-report

12. History of schizophrenia or psychotic disorder DSM-5 diagnosis

13. Current DSM-5 diagnosis of untreated/unstable panic disorder, bipolar disorder, PTSD, eating disorder, major depression (if stable for >30 days, eligible with clinician approval)