Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beau Nakamoto
• Collaborators: Hawaii Pacific Health; National Institute of Neurological Disorders and Stroke (NINDS); University of Hawaii
• Treatments: Ferrosoferric Oxide

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