Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2015-02-28
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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HIV+ with neurocognitive disorder
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
Ferumoxytol
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
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
Ferumoxytol
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
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
Ferumoxytol
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
Interventions
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Ferumoxytol
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
65 Years
ALL
Yes
Sponsors
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Hawaii Pacific Health
OTHER
University of Hawaii
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Beau Nakamoto
OTHER
Responsible Party
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Beau Nakamoto
Assistant Professor of Medicine
Principal Investigators
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Beau Nakamoto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Hawaii
Locations
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Hawaii Center for AIDS
Honolulu, Hawaii, United States
Countries
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Other Identifiers
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H032
Identifier Type: OTHER
Identifier Source: secondary_id
2013-077
Identifier Type: -
Identifier Source: org_study_id