Trial Outcomes & Findings for PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects (NCT NCT03581305)
NCT ID: NCT03581305
Last Updated: 2023-03-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
90 minutes of scanning
Results posted on
2023-03-21
Participant Flow
Subjects were recruited through protocol number 13-N-0149, other IRB- approved intramural NIH protocols, or through referrals from outside providers/ institutions or self-referred. Once consented and found eligible, subjects underwent PET scanning using 18FDOPA and / or 11C-DASB. All visits were on a outpatient basis. There were not follow-up visits after the completion of the PET scan(s) The recruitment and enrollment process for this study occurred from 11/20/2018 through 11/5/2021
Among HIV positive subjects: 1 subject didn't show up to either scan 2 subjects couldn't finish FDOPA and didn't come back for DASB 2 subjects did FDOPA but didn't come back for DASB Among HIV negative subjects 1 subject did DASB but didn't come back for FDOPA
Participant milestones
| Measure |
HIV Positive Participants
* 25 eligible HIV-infected participants for the dopaminergic arm Plan: 18F-FDOPA PET: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
* 20 HIV-infected individuals for the serotonergic arm Plan: 11C-DASB: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
|
HIV Negative Participants
* 50 eligible HIV-negative participants for the dopaminergic arm Plan: 18F-FDOPA PET: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
* 20 HIV-negative participants for the serotonergic arm Plan: 11C-DASB: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
|
|---|---|---|
|
Dopaminergic Study
STARTED
|
23
|
23
|
|
Dopaminergic Study
COMPLETED
|
20
|
22
|
|
Dopaminergic Study
NOT COMPLETED
|
3
|
1
|
|
Serotonergic Study
STARTED
|
23
|
23
|
|
Serotonergic Study
COMPLETED
|
18
|
22
|
|
Serotonergic Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
HIV Positive Participants
* 25 eligible HIV-infected participants for the dopaminergic arm Plan: 18F-FDOPA PET: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
* 20 HIV-infected individuals for the serotonergic arm Plan: 11C-DASB: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
|
HIV Negative Participants
* 50 eligible HIV-negative participants for the dopaminergic arm Plan: 18F-FDOPA PET: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
* 20 HIV-negative participants for the serotonergic arm Plan: 11C-DASB: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
|
|---|---|---|
|
Dopaminergic Study
Withdrawal by Subject
|
1
|
1
|
|
Dopaminergic Study
could not finish FDOPA scan
|
2
|
0
|
|
Serotonergic Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
Baseline characteristics by cohort
| Measure |
HIV Positive Participants (Dopaminergic and Serotonergic Studies)
n=23 Participants
25 eligible HIV-infected individuals for the dopaminergic arm
18F-FDOPA: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
20 eligible HIV-infected individuals for the serotonergic arm
11C-DASB: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
|
HIV Negative Participants (Dopaminergic and Serotonergic Studies)
n=23 Participants
50 eligible HIV-negative (HIV-) individuals for the dopaminergic arm
18F-FDOPA: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
20 eligible HIV-negative individuals for the serotonergic arm
11C-DASB: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=23 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=43 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=20 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
21 Participants
n=23 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
39 Participants
n=43 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Age, Categorical
>=65 years
|
2 Participants
n=20 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
2 Participants
n=23 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
4 Participants
n=43 Participants • those are the screened participants who completed the study (participants in either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
9 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
15 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
14 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
28 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
13 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
22 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
White
|
11 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
10 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
21 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=23 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
0 Participants
n=43 Participants • Those are the participants who completed the study (either the serotonergic or dopaminergic studies or both) separated by HIV status
|
|
participant numbers
|
20 Participants
n=20 Participants • Those are the participants who completed either the serotonergic or dopaminergic studies or both, separated by HIV status
|
23 Participants
n=23 Participants • Those are the participants who completed either the serotonergic or dopaminergic studies or both, separated by HIV status
|
43 Participants
n=43 Participants • Those are the participants who completed either the serotonergic or dopaminergic studies or both, separated by HIV status
|
PRIMARY outcome
Timeframe: 90 minutes of scanningPopulation: All participants who completed FDOPA PET scan with usable Data
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.
Outcome measures
| Measure |
Dopaminergic Arm Group A
n=19 Participants
25 eligible HIV-infected individuals for the dopaminergic arm.
Dopaminergic arm:
Group A: HIV-positive subjects with or without co- morbidities;
18F-FDOPA: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
|
Dopaminergic Arm Group B/C
n=20 Participants
50 eligible HIV-negative (HIV-) individuals for the dopaminergic arm.
Group B: HIV-negative subjects with co-morbidities; Group C: HIV-negative subjects without co-morbidities
18F-FDOPA: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
|
|---|---|---|
|
Influx Constant (Ki) for 18F-FDOPA PET.
Caudate
|
0.01415 min-1
Standard Deviation 0.00136
|
0.01409 min-1
Standard Deviation 0.00126
|
|
Influx Constant (Ki) for 18F-FDOPA PET.
Putamen
|
0.01588 min-1
Standard Deviation 0.00127
|
0.01592 min-1
Standard Deviation 0.00127
|
PRIMARY outcome
Timeframe: 90 minutes of scanningBinding 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.
Outcome measures
| Measure |
Dopaminergic Arm Group A
n=17 Participants
25 eligible HIV-infected individuals for the dopaminergic arm.
Dopaminergic arm:
Group A: HIV-positive subjects with or without co- morbidities;
18F-FDOPA: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
|
Dopaminergic Arm Group B/C
n=19 Participants
50 eligible HIV-negative (HIV-) individuals for the dopaminergic arm.
Group B: HIV-negative subjects with co-morbidities; Group C: HIV-negative subjects without co-morbidities
18F-FDOPA: High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
|
|---|---|---|
|
11C-DASB PET Binding Potential
|
2.949 unitless
Standard Deviation 0.395
|
3.256 unitless
Standard Deviation 0.597
|
SECONDARY outcome
Timeframe: Study and statistical analysis CompletionCorrelation of 18F-FDOPA uptake in the brain with co-morbidities such as cardiovascular disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study and statistical analysis CompletionCorrelation of 18F-FDOPA and 11C-DASB with HIV infection parameters (e.g. time since HIV diagnosis, duration of infection before treatment initiation, nadir CD4).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study and statistical analysis CompletionCorrelation of 11C-DASB with Neuropsychiatric evaluation (e.g. depressive and executive function/cognitive scores).
Outcome measures
Outcome data not reported
Adverse Events
HIV Positive Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Negative Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place