Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
AIDS Dementia Complex
About this trial
This is an interventional screening trial for AIDS Dementia Complex focused on measuring HIV, Dementia, Neuroimaging
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Hawaii Center for AIDS
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
HIV+ with neurocognitive disorder
HIV+ without neurocognitive impairment
HIV- without neurocognitive impairment
All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion
All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion
All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion