PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects (NCT03581305) | Clinical Trial Compass
CompletedPhase 1
PET Imaging of the Dopaminergic and Serotonergic Systems in Treated HIV Positive Subjects
United States46 participantsStarted 2018-11-20
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Men and women, 18-70 years of age
✓. Ability to sign informed consent by the subject
✓. Subjects may be enrolled in or have been discharged from IRB approved NIH protocols OR subjects may be referred from outside providers/institutions.
✓. Has the ability to be seen by an outside medical doctor who provides care.
✓. Known and documented HIV-1 infection
✓. Plasma HIV-RNA BLD (\<100 copies/mm3) for greater than one year since the last available documented viral load measurement..
✓. At least one year of continuous ART prior to last documented suppressed viral load measurement and no history of ART modification or interruption since then.
✓. HIV-antibody negative
Exclusion criteria
✕. Illness or other condition that, in the opinion of the PI, may interfere with study participation at the time of enrollment, including known history of significant intracranial structural damage such as previous stroke(s) or history of intracranial benign or malignant tumors.
What they're measuring
1
Influx Constant (Ki) for 18F-FDOPA PET.
Timeframe: 90 minutes of scanning
2
11C-DASB PET Binding Potential
Timeframe: 90 minutes of scanning
Trial details
NCT IDNCT03581305
SponsorNational Institutes of Health Clinical Center (CC)
✕. Conditions other than HAND associated with cognitive impairment or dementia such as Alzheimer s, Parkinson s disease, head injury with loss of consciousness \>30 minutes, or seizure disorders.
✕. A positive screening result for psychiatric diseases that are known to affect the dopaminergic or serotonergic systems.
✕. Current substance abuse that would interfere with PET scan results at the investigators discretion.
✕. Medications: use of any drug with known dopaminergic or serotonergic activity within 6 months prior to planned imaging date(s).
✕. Pregnant or Lactating women: Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry. Pregnancy testing will also be performed in enrolled female participants prior to any radiation exposure.
✕. Prior or planned/anticipated exposure to radiation due to clinical care or participation in other research protocols, which would exceed the recommended acceptable annual limit of radiation exposure once accounting for the requirements of the current study.
✕. Use of any of the following drugs within 6 months from planned imaging date(s):