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Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

Primary Purpose

AIDS Dementia Complex

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ferumoxytol
Sponsored by
Beau Nakamoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for AIDS Dementia Complex focused on measuring HIV, Dementia, Neuroimaging

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

HIV+ with neurocognitive disorder

HIV+ without neurocognitive impairment

HIV- without neurocognitive impairment

Arm Description

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

Outcomes

Primary Outcome Measures

Change in the proportion of abnormal MRIs
The proportion of abnormal MRIs will be compared for each group.

Secondary Outcome Measures

Change in quantitative susceptibility mapping (QSM)
Use of QSM to quantitate ferumoxytol accumulation in the brain

Full Information

First Posted
February 2, 2016
Last Updated
October 25, 2017
Sponsor
Beau Nakamoto
Collaborators
Hawaii Pacific Health, University of Hawaii, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02678767
Brief Title
Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
Official Title
Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Beau Nakamoto
Collaborators
Hawaii Pacific Health, University of Hawaii, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Dementia Complex
Keywords
HIV, Dementia, Neuroimaging

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV+ with neurocognitive disorder
Arm Type
Experimental
Arm Description
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
Arm Title
HIV+ without neurocognitive impairment
Arm Type
Active Comparator
Arm Description
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
Arm Title
HIV- without neurocognitive impairment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the proportion of abnormal MRIs
Description
The proportion of abnormal MRIs will be compared for each group.
Time Frame
Change from Baseline MRI at 4-6 weeks post-infusion MRI
Secondary Outcome Measure Information:
Title
Change in quantitative susceptibility mapping (QSM)
Description
Use of QSM to quantitate ferumoxytol accumulation in the brain
Time Frame
Change from Baseline MRI at 4-6 weeks post-infusion MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beau Nakamoto, MD, PhD
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawaii Center for AIDS
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

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