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NCT03581305 · ClinicalTrials.gov registry record · Phase 1
PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT03581305: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT03581305 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03581305, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
Background: Human immunodeficiency virus (HIV) infection is a serious disease with no cure. Some people with HIV have depression and other mood problems. They can have problems with thinking and memory. Researchers think 2 chemicals in the brain may cause those problems. The chemicals are serotonin and dopamine. The researchers want to take images to learn more about those chemicals in HIV patients. Objective: To learn how HIV affects serotonin and dopamine in the brain. Eligibility: Adults ages 18-70 with HIV who have been on antiretroviral treatment for at least 1 year Healthy adults ages 18-70 All participants must be already enrolled in protocol 13-N-0149. Design: * Participants will be screened with a urine drug test. The results could be shared with insurance companies. * Participants who could be pregnant will have a pregnancy test. * Participants may have a physical exam and blood tests. * Participants will have 1 or 2 positron emission tomography (PET) scans. A needle will guide a thin plastic tube (catheter) into an arm vein. A radioactive drug will be injected into the plastic tube. This is a tracer that helps researchers understand the PET images. * Participants who have the dopamine scan will have to fast for 4-6 hours before the scan. They will take a pill to help direct the tracer to the brain one hour before the scan. * Each scan will last about 1.5 hours. * Participants will be asked to drink a lot of fluids and empty their bladder frequently for the rest of the day after each scan.
Primary Outcome
in order to learn how HIV affects dopamine in the brain, we performed dynamic PET scans for 90 minutes in each patient, after injection of FDOPA. Analysis: After the scans were reconstructed, we extracted the Time activity curves and performed compartmental analysis using Patlak linear graphical analysis with reference region. The extracted outcome measure is the influx constant referred to as Ki and reflecting the rate of FDOPA uptake in specific brain regions.
Interventions
- DRUG 18F-FDOPA
- DRUG 11C-DASB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 1 |
What the finished NCT03581305 record still lists
NCT03581305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which 18F-FDOPA is the first listed.
NCT03581305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03581305 about?
NCT03581305 is a clinical study titled "PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects". Background: Human immunodeficiency virus (HIV) infection is a serious disease with no cure. Some people with HIV have depression and other mood problems. They can have problems with thinking and memory. Researchers think 2 chemicals in the brain may cause those problems. The chemicals are serotonin...
What is the current status of trial NCT03581305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2018-11-20. Estimated completion is 2022-04-06.
What interventions are being tested in trial NCT03581305?
The interventions under investigation include: 18F-FDOPA (DRUG), 11C-DASB (DRUG).
Who is sponsoring clinical trial NCT03581305?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03581305's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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