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Completed Phase 1 Interventional Accepts healthy volunteers Results available

PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects

ClinicalTrials.gov ID: NCT03581305

Public ClinicalTrials.gov record NCT03581305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03581305
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
46 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 19, 2018
Primary completion
Apr 5, 2022
Completion
Apr 5, 2022
Last update posted
Mar 20, 2023

2018 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03581305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 20, 2023 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03581305 live on ClinicalTrials.gov.

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