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Evaluation of Neuroinflammation FNOS PET/CT in HIV (+) and (-) Subjects With OUD and Healthy Controls

NCT04401917

Active Not RecruitingEARLY_Phase 1

Sponsor: University of Pennsylvania

Conditions: HIV Infections, Opioid Use

Interventions: [18F]NOS

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

INCLUSION CRITERIA

Cohort A (HIV+/OUD+):

1. 18-65 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. OUD positive (+): Participants will meet DSM-5 criteria for lifetime OUD and will be on a stable dosage of OUD treatment for at least four weeks prior to the screening visit.
4. 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)

Cohort B (HIV-/OUD+):

1. 18-65 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. OUD positive (+): Participants will meet DSM-5 criteria for lifetime OUD and will be on a stable dosage of OUD treatment for at least four weeks prior to the screening visit.
4. HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test at screening.

Cohort C (HIV+/OUD-):

1. 18-65 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. OUD negative (-): During the past year, must not meet criteria for lifetime OUD (as per DSM-5) and cannot have used an opioid for any reason in the past 30 days prior to screening as evidenced by self-report, medical record review, and urine drug testing at screening.
4. HIV positive (+): Diagnosed with HIV-1 infection per medical record review. Requirements for study participation for HIV+ participants:

Cohort D (HIV-/OUD-, Healthy Controls):

1. 18-65 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. OUD negative (-): Must not meet criteria for lifetime OUD (as per DSM-5) and cannot have used an opioid for any reason in the past 30 days prior to screening as evidenced by self-report, medical record review, and urine drug testing at screening.
4. HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test at screening.

EXCLUSION CRITERIA

1. 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 at the screening visit and within one day of the PET/CT scan.
2. At screening, the participant's weight is \> 350 lb.
3. 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.
4. 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.
5. 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.
6. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report
7. 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
8. History of schizophrenia or psychotic disorder DSM-5 diagnosis
9. Current psychiatric disorder (bipolar, schizophrenia, eating disorder and major depression with suicidal ideation, or psychotic features) identified by clinical examination or the structured interview that could interfere with study participation or make it hazardous for the subject.
10. Self-reported current alcohol consumption of greater than or equal to 15 standard drinks per week on average 30 days prior to screening visit
11. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
12. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-report that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study

Locations (1)

Philadelphia, Pennsylvania, United States