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Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

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ClinicalTrials.gov Identifier: NCT02678767
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Hawaii Pacific Health
University of Hawaii
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Beau Nakamoto, University of Hawaii

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
AIDS Dementia Complex Drug: Ferumoxytol Phase 2

Detailed Description:
HIV-associated neurocognitive disorders (HAND) continue to be prevalent despite effective combination antiretroviral therapy (cART) and have a significant impact on morbidity and quality of life. Monocytes/macrophages (M/MΦ) are believed to play a critical role in the pathogenesis of HAND. Neuroimaging HIV research has not focused on assessing M/MΦ-mediated inflammation in the brain. Currently, no neuroimaging modality exists that can define the extent of active inflammation due to M/MΦ in HAND either as a clinical diagnostic tool or to assist in defining objective improvement in clinical trials addressing HAND. Ferumoxytol is an ultra-small iron oxide MRI contrast agent avidly taken up by circulating M/MΦ. The investigators hypothesize that ferumoxytol-based imaging can identify ongoing inflammation due to perivascular M/MΦ which is believed to represent a key pathologic correlate of HAND.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS
Study Start Date : February 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia HIV/AIDS
Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: 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
Drug: 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 Name: Feraheme

Active Comparator: 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
Drug: 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 Name: Feraheme

Active Comparator: 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
Drug: 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 Name: Feraheme




Primary Outcome Measures :
  1. Change in the proportion of abnormal MRIs [ Time Frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI ]
    The proportion of abnormal MRIs will be compared for each group.


Secondary Outcome Measures :
  1. Change in quantitative susceptibility mapping (QSM) [ Time Frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI ]
    Use of QSM to quantitate ferumoxytol accumulation in the brain



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678767


Locations
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United States, Hawaii
Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Beau Nakamoto
Hawaii Pacific Health
University of Hawaii
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Beau Nakamoto, MD, PhD University of Hawaii
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Responsible Party: Beau Nakamoto, Assistant Professor of Medicine, University of Hawaii
ClinicalTrials.gov Identifier: NCT02678767    
Other Study ID Numbers: 2013-077
H032 ( Other Identifier: Hawaii Center for AIDS )
1R21NS087951-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Beau Nakamoto, University of Hawaii:
HIV
Dementia
Neuroimaging
Additional relevant MeSH terms:
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AIDS Dementia Complex
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions