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

NCT04401917 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 842717
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Opioid Use

Outcome Measures

Primary Outcomes (3)

• Comparing the patterns of [18F]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan

  comparing the patterns of \[18F\]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan. Comparing the whole brain \[18F\]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.

  3 years

• Comparing the patterns of [18F]NOS brain uptake in HIV+ vs. HIV- subjects using PET/Ct scna

  Comparing the patterns of \[18F\]NOS brain uptake in HIV+ vs. HIV- using PET/CT scan. Comparing the whole brain \[18F\]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.

  3 years

• Compare patterns of [18F]NOS brain uptake as a function of the interaction of OUD and HIV status.

  compare patterns of \[18F\]NOS brain uptake as a function of the interaction of OUD and HIV status

  3 years

Secondary Outcomes (2)

• Compare patterns of [18F]NOS brain uptake in regions implicated in HIV and OUD

  3 years

• Comparing peripheral blood inflammatory biomarkers as a function of both the main and interactive effects of OUD and HIV status

  3 years

Study Arms (4)

HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)

OTHER

HIV positive (HIV+) subjects with Opioid Use Disorder (OUD): HIV+/OUD+

Drug: [18F]NOS

HIV negative (HIV-) subjects with OUD

OTHER

HIV negative (HIV-) subjects with OUD: HIV-/OUD+

Drug: [18F]NOS

HIV Positive (HIV+) subjects with OUD negative

OTHER

HIV+ subjects who may have been opioid-exposed but do not have current or past OUD

Drug: [18F]NOS

Healthy volunteer

OTHER

HIV-, OUD- healthy controls who have been opioid-exposed but do not have current or past OUD

Drug: [18F]NOS

Interventions

[18F]NOS DRUG

Participants will undergo approximately 60 minutes of dynamic whole-body scanning, including the brain, starting at approximately the time of injection of \[18F\]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of \[18F\]NOS.

Also known as: [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine

HIV Positive (HIV+) subjects with OUD negative; HIV negative (HIV-) subjects with OUD; HIV positive (HIV+) subjects with Opioid Use Disorder (OUD); Healthy volunteer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A (HIV+/OUD+):
• years of age
• 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.
• 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.
• 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+):
• years of age
• 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.
• 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.
• HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test at screening.
• Cohort C (HIV+/OUD-):
• years of age

You may not qualify if:

• 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.
• At screening, the participant's weight is \> 350 lb.
• 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.
• 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.
• 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.
• History of epilepsy or seizure disorder as assessed by medical record review and/or self-report
• 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
• History of schizophrenia or psychotic disorder DSM-5 diagnosis
• 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.
• Self-reported current alcohol consumption of greater than or equal to 15 standard drinks per week on average 30 days prior to screening visit
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Fluorine-18

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jacob Dubroff, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 26, 2020
• Study Start: December 7, 2020
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)