NCT03581305

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

Completed Phase 1 Results posted Last updated 21 March 2023

What this trial tests

Phase 1 trial testing 18F-FDOPA in Depression in 46 participants. Completed in 6 April 2022.

Timeline

20 November 2018

Primary endpoint
6 April 2022

6 April 2022

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	46
Start date	20 November 2018
Primary completion	6 April 2022
Estimated completion	6 April 2022
Sites	1 location across United States

Drugs / interventions tested

• 18F-FDOPA — full drug profile →
• 11C-DASB

Conditions studied

• Depression — all drugs for Depression →
• HIV Infections — all drugs for HIV Infections →
• HIV-Associated Cognitive Motor Complex — all drugs for HIV-Associated Cognitive Motor Complex →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 70, any sex, with Depression or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Influx Constant (Ki) for 18F-FDOPA PET. Primary · 90 minutes of scanning

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.

Caudate

Group	Value	95% CI
Dopaminergic Arm Group A	0.01415	± 0.00136
Dopaminergic Arm Group B/C	0.01409	± 0.00126

Putamen

Group	Value	95% CI
Dopaminergic Arm Group A	0.01588	± 0.00127
Dopaminergic Arm Group B/C	0.01592	± 0.00127

11C-DASB PET Binding Potential Primary · 90 minutes of scanning

Binding potential is a measure of the density of available serotonin transporter in specific brain locations. This is extracted from time activity curves of dynamic PET data acquired over 90 minutes after injection of 11C-DASB.

Group	Value	95% CI
Serotonergic Arm Group D	2.949	± 0.395
Serotonergic Arm Group E	3.256	± 0.597

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Serotonergic and Dopaminergic Function in Neuropsychiatrically Asymptomatic People With HIV on Antiretroviral Therapy.
   Lau CY, Lyndaker A, Shah S, Wakim P, et al · · 2025 · PMID 40400173 · DOI 10.1002/acn3.70074