Ferumoxytol-enhanced Brain MRI in HIV-associated Neurocognitive Disorders

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the radiologic findings on brain MRI after ferumoxytol administration in HIV-infected patients with cognitive impairment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hawaii
• Collaborator: Oregon Health and Science University
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• HIV-1 infection as documented by ELISA and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA by RT-PCR or DNA at any time prior to study entry.

• Receipt of antiretroviral (ARV) medication uninterrupted for at least 6 months leading up to the screening period with demonstrated plasma HIV RNA < 48 copies/ml within the last 6 months.

• Willingness for both males and females of childbearing potential to utilize 2 effective contraception methods (2 separate forms, one of which must be an effective barrier method), be non-heterosexually active or have a an exclusive vasectomized partner from screening throughout the duration of the study treatment and for 30 days following the last dose of study drugs.

• Age >18 years.

• Ability and willingness to provide written informed consent

• HIV DNA > 10 copies/106 CD14+ PBMCs

• Mild or greater cognitive impairment as indicated by global NPZ8 z-score < -0.5 with a neurocognitive abnormality (defined as a z-score < -0.5) in at least one cognitive domain characteristic of HAD (i.e., executive function, psychomotor speed, memory).

Exclusion Criteria:

• Requirement for acute therapy for other AIDS-defining illness or other serious medical illnesses (in the opinion of the site investigator) within 14 days prior to study entry.

• Known allergic or hypersensitivity reaction to FERAHEME, parental iron, parental dextran, parental iron-dextran, or parental iron-polysaccharide preparations

• Known history of an iron overload syndrome (e.g., hereditary hemochromatosis, porphyria cutanea tarda)

• Medical conditions (e.g., chronic hemolytic anemia) which requires frequent blood transfusions

• Taking oral iron supplementation

• Any factor that precludes MRI scan including presence of metal or exposure to metal work (e.g. metal grinder/worker) and claustrophobia

• Past or present HIV opportunistic infection of the brain, learning disability, head injury with prolonged loss of consciousness or cognitive sequelae, or other non-HIV risk factor that in the opinion of the principal investigator (PI) may impact cognitive performance.

• History of epilepsy requiring treatment with an antiepileptic

• Other chronic illnesses including insulin-dependent diabetes, autoimmune diseases, and endocrinopathies, except subjects on stable physiologic replacement therapy for low testosterone or thyroid levels

• Current active substance or alcohol dependence or positive urine toxicology screen.

• Pregnancy or breast-feeding, intent to become pregnant during the course of the study.

• Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study

• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) greater than 2x upper limits of normal on pre-entry baseline laboratory safety assessment prior to study enrollment.

• Elevated iron levels on pre-entry baseline laboratory safety assessment prior to study enrollment.

• Hematocrit > 52% or Hemoglobin > 18 g/dL on pre-entry baseline laboratory safety assessment prior to study enrollment.