Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
Completed · Phase 2
Conditions studied: AIDS Dementia Complex
In brief
This project will investigate the ability of a novel MRI contrast agent to identify and quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of HIV-infected individuals.
Key facts
- Study ID
- NCT02678767
- Run by
- Beau Nakamoto
- People needed
- 30
- Starts
- 2015-02-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2017-10-27
Who can join
Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 40-65 years
- Plasma HIV RNA < 48 copies/ml (HIV+ subjects only)
- On stable cART >= 1 year (HIV+ subjects only)
- Global neuropsychological (NP) score <-0.5 in at least one cognitive domain known to be affected by HIV (neurocognitively impaired subjects only)
- Documentation of negative HIV infection by an FDA approved test (HIV- subjects only)
You may not qualify if…
- Active substance use
- History of myocardial infarct or stroke
- Diabetes
- Chronic hepatitis C virus (HCV) infection
- Uncontrolled major affective disorder, active psychosis, central nervous system disease that affects the brain structure, or other uncontrolled chronic medical condition that in the opinion of the investigator may impact NP testing or the study outcome
- Psychoactive or other medications which may impact NP testing
- Factors that preclude MRI
- Known hypersensitivity to ferumoxytol
- History of laboratory measurements consistent with an iron overload syndrome
- Medical conditions that require frequent blood transfusions
- Taking oral iron supplements
- Elevated iron levels
- Any condition, which in the opinion of the investigator, would compromise the subject's ability to participate
- Multiple drug allergies that may pose a greater risk of anaphylaxis associated with ferumoxytol
- Pregnant, unwillingness to practice birth control, or breastfeeding
- Unable to give informed consent
Where it is running
- Hawaii Center for AIDS — Honolulu, Hawaii, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.