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[18F]NOS PET/CT Scan for Neuroinflammation

Q: Are there still openings for volunteers in this experiment?

Affirmatively, the information on clinicaltrials.gov demonstrates that this research is presently searching for participants. The study was originally posted in December of 2020 and most recently updated November of 2022.

Q: What criteria must potential participants fulfill in order to be eligible for this research?

This clinical trial is seeking 60 individuals aged 18-60 who have a <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> diagnosis. Furthermore, participants must present with an undetectable viral load within the last year, be informed of the <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> nature of this study and provide written consent for participation in accordance to institutional guidelines, demonstrate no opioid use in the past 30 days prior to screening as determined by self-report and drug testing at screening, maintain stable ART treatment regimen for four weeks before their initial visit, and possess a CD4+ count greater than 200 cells/mm3 from medical records review within 12 months preceding screening.

Q: How many participants are encompassed by this research endeavor?

Affirmative. The clinical trial registry shows that this study, originally posted on December 7th 2020, is currently recruiting participants. Approximately 60 individuals are required from 1 location to enrol in the trial.

Q: Does the participant criteria for this experiment preclude individuals under 45 years of age?

This research initiative is considering members of the public that are between legal adulthood and 60 years old.

Phase < 1

Recruiting

Led By Jacob Dubroff, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is measuring the amount of inflammation in the brain by using a radioactive tracer and PET/CT scan.

Who is the study for?

This trial is for adults aged 18-65 with or without HIV and opioid use disorder (OUD). Participants must have stable health conditions, including a controlled viral load if HIV positive, and be on consistent OUD treatment if applicable. Pregnant or breastfeeding women, individuals over 350 lb, those with claustrophobia affecting scans, MRI contraindications like incompatible metal in the body, significant organ dysfunction, epilepsy/seizure disorders, severe head trauma history, certain psychiatric disorders including schizophrenia or active major depression with suicidal ideation are excluded.Check my eligibility

What is being tested?

The study tests how a radioactive tracer called [18F]NOS behaves in the brain to measure inflammation levels using PET/CT imaging. It involves an injection of [18F]NOS followed by about an hour-long dynamic brain scan. The research includes people both with and without HIV/OUD to compare results across different health statuses.See study design

What are the potential side effects?

Potential side effects may include reactions related to the radioactive tracer such as discomfort at the injection site or allergic reactions. Since it's an imaging study involving radiation exposure from PET/CT scans there's also a small increased risk of cancer from radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Brain

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

Secondary outcome measures

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

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Healthy volunteerExperimental Treatment1 Intervention

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

Group II: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)Experimental Treatment1 Intervention

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

Group III: HIV negative (HIV-) subjects with OUDExperimental Treatment1 Intervention

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

Group IV: HIV Positive (HIV+) subjects with OUD negativeExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,939 Total Patients Enrolled

Jacob Dubroff, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania

4 Previous Clinical Trials

279 Total Patients Enrolled

Media Library

HIV Positive (HIV+) subjects with OUD negative Clinical Trial Eligibility Overview. Trial Name: NCT04401917 — Phase < 1

Human Immunodeficiency Virus Infection Research Study Groups: HIV Positive (HIV+) subjects with OUD negative, HIV positive (HIV+) subjects with Opioid Use Disorder (OUD), Healthy volunteer, HIV negative (HIV-) subjects with OUD

Human Immunodeficiency Virus Infection Clinical Trial 2023: HIV Positive (HIV+) subjects with OUD negative Highlights & Side Effects. Trial Name: NCT04401917 — Phase < 1

HIV Positive (HIV+) subjects with OUD negative 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401917 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for volunteers in this experiment?

"Affirmatively, the information on clinicaltrials.gov demonstrates that this research is presently searching for participants. The study was originally posted in December of 2020 and most recently updated November of 2022."

Answered by AI

What criteria must potential participants fulfill in order to be eligible for this research?

"This clinical trial is seeking 60 individuals aged 18-60 who have a HIV diagnosis. Furthermore, participants must present with an undetectable viral load within the last year, be informed of the experimental nature of this study and provide written consent for participation in accordance to institutional guidelines, demonstrate no opioid use in the past 30 days prior to screening as determined by self-report and drug testing at screening, maintain stable ART treatment regimen for four weeks before their initial visit, and possess a CD4+ count greater than 200 cells/mm3 from medical records review within 12 months preceding screening."

Answered by AI

How many participants are encompassed by this research endeavor?

"Affirmative. The clinical trial registry shows that this study, originally posted on December 7th 2020, is currently recruiting participants. Approximately 60 individuals are required from 1 location to enrol in the trial."

Answered by AI