Measuring brain inflammation in HIV and opioid use disorder patients

Evaluation of in Vivo Neuroinflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in HIV Positive and Negative Subjects With Opioid Use Disorder and Healthy Controls

This study is testing how HIV and opioid use affect brain inflammation in people with these conditions compared to healthy individuals.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Pennsylvania (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT04401917 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the level of neuroinflammation in the brain among different groups, including individuals with HIV, those with Opioid Use Disorder (OUD), and healthy controls. Participants will receive a radioactive tracer called [18F]NOS, which will be injected and then monitored using a PET/CT scan for approximately 60 minutes. The study seeks to understand how opioids and HIV may interact to affect brain inflammation and immune function. Participants must have had a brain MRI within the past year or will undergo one after consenting to the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 who are either HIV positive with OUD or have OUD without HIV.

Not a fit: Patients who do not have HIV or OUD, or those outside the age range of 18-65, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and treatment strategies for patients with HIV and opioid use disorder.

How similar studies have performed: Other studies have indicated that examining neuroinflammation in similar populations may yield valuable insights, but this specific approach using [18F]NOS is relatively novel.

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:

   * 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 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

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Jacob Dubroff, MD, PhD — University of Pennsylvania
• Study coordinator: Erin Schubert

Conditions HIV Infections; Opioid Use