Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

NCT02678767 | Completed Phase 2 DMC

• 3 other identifiers: 2013-077H0321R21NS087951-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS Dementia Complex

Keywords

HIV; Dementia; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of abnormal MRIs

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

  Change from Baseline MRI at 4-6 weeks post-infusion MRI

Secondary Outcomes (1)

• Change in quantitative susceptibility mapping (QSM)

  Change from Baseline MRI at 4-6 weeks post-infusion MRI

Study Arms (3)

HIV+ with neurocognitive disorder

EXPERIMENTAL

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

HIV+ without neurocognitive impairment

ACTIVE COMPARATOR

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

HIV- without neurocognitive impairment

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Feraheme

HIV+ with neurocognitive disorder; HIV+ without neurocognitive impairment; HIV- without neurocognitive impairment

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beau Nakamoto: lead
• Hawaii Pacific Health: collaborator
• University of Hawaii: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Hawaii Center for AIDS

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

AIDS Dementia Complex; Dementia

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Beau Nakamoto, MD, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 10, 2016
• Study Start: February 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)