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

Who is this study for? Patients with Human Immunodeficiency Virus
What treatments are being studied? FNOS
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 18-60 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.

• 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.

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
Recruiting
Philadelphia
Contact Information
Primary
Erin Schubert
erinschu@pennmedicine.upenn.edu
215-662-3041
Time Frame
Start Date: December 7, 2020
Estimated Completion Date: December 7, 2024
Participants
Target number of participants: 60
Treatments
Other: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)
HIV positive (HIV+) subjects with Opioid Use Disorder (OUD): HIV+/OUD+
Other: HIV negative (HIV-) subjects with OUD
HIV negative (HIV-) subjects with OUD: HIV-/OUD+
Other: HIV Positive (HIV+) subjects with OUD negative
HIV+ subjects who may have been opioid-exposed but do not have current or past OUD
Other: Healthy volunteer
HIV-, OUD- healthy controls who have been opioid-exposed but do not have current or past OUD
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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