CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
18F-FDOPA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03581305
NCT03581305Phase 1Completed

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

National Institutes of Health Clinical Center (CC)·interventional·Posted Jul 10, 2018·Updated Mar 21, 2023

In Brief

A Phase 1 clinical trial evaluating 18F-FDOPA and 11C-DASB for Depression and 2 related conditions. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJul 10, 2018
Enrollment StartNov 20, 2018
Primary CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.0 years ago

Interventions

18F-FDOPAdrug

High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.

11C-DASBdrug

High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.