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Completed

NCT Number: NCT02678767

Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

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.

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Key information

Conditions

AIDS Dementia Complex Blood-Borne Infections Brain Diseases Central Nervous System Diseases Communicable Diseases Dementia Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Nervous System Diseases Neurocognitive Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hawaii Center for AIDS

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferumoxytol

Drug

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 names: Feraheme

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beau Nakamoto

Other

Collaborators

  • Hawaii Pacific Health
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Hawaii

Registry information

Official study title

Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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