Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT03581305
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2018-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects
Status:
COMPLETED
Status Verified Date:
2022-04-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Background: An extensive body of literature points towards neuronal brain injury in human immunodeficiency virus positive (HIV-positive) subjects despite virological suppression of the virus in the periphery under the effect of antiretroviral therapies (ART). Existing evidence suggests that the central nervous system (CNS) could be an important reservoir for human immunodeficiency virus (HIV) regardless of cumulative time on treatment. This results in progressive neurocognitive dysfunction despite optimal treatment and peripheral control of the infection. Even though structural imaging studies have described abnormalities in optimally-treated HIV-positive subject population, there has been only a few attempts at deciphering the cellular levels of brain damage in those subjects using in vivo molecular imaging biomarkers. As part of CNS involvement, specific neurotransmitter systems including the dopaminergic and serotonergic systems are thought to be affected by the infection with distinct neurological, cognitive and psychological manifestations, even in optimally-treated subjects.
Objective: This protocol aims at identifying aspects of dopaminergic and serotonergic dysfunction in optimally-treated HIV-positive subjects using high resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) and serotonergic (11C-DASB) systems.
Study population: We will identify 25 eligible HIV-infected individuals and 50 eligible HIV-negative (HIV-) individuals for the dopaminergic arm, and 20 HIV-infected individuals and 20 HIV-negative individuals for the serotonergic arm. Subjects will be selected from IRB approved NIH protocols, self-referred or will be referred form outside providers/institutions and those who meet eligibility criteria will be offered enrollment in our study.
Design: Subjects will undergo either a one-time 18F-FDOPA PET scan or a one-time 11C-DASB PET scan or both, if eligible. HIV-positive subjects and HIV-negative individuals will be included in the study.
Outcome Measures: Influx constant (Ki) for 18F-FDOPA PET and Binding potential relative to
non-displaceable binding (BPND) values for 11C-DASB PET
Objective: This protocol aims at identifying aspects of dopaminergic and serotonergic dysfunction in optimally-treated HIV-positive subjects using high resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) and serotonergic (11C-DASB) systems.
Study population: We will identify 25 eligible HIV-infected individuals and 50 eligible HIV-negative (HIV-) individuals for the dopaminergic arm, and 20 HIV-infected individuals and 20 HIV-negative individuals for the serotonergic arm. Subjects will be selected from IRB approved NIH protocols, self-referred or will be referred form outside providers/institutions and those who meet eligibility criteria will be offered enrollment in our study.
Design: Subjects will undergo either a one-time 18F-FDOPA PET scan or a one-time 11C-DASB PET scan or both, if eligible. HIV-positive subjects and HIV-negative individuals will be included in the study.
Outcome Measures: Influx constant (Ki) for 18F-FDOPA PET and Binding potential relative to
non-displaceable binding (BPND) values for 11C-DASB PET
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-CC-0117 | OTHER | NIH protocol number | View |