HIV Dementia Clinical Trial
Official title:
Neuroimaging Correlates of Monocyte/Macrophage Infiltration in HIV-infected Individuals: A Cross-sectional Pilot Study Using IV Ferumoxytol
The purpose of this study is to describe the radiologic findings on brain MRI after ferumoxytol administration in HIV-infected patients with cognitive impairment.
The continued existence of cognitive dysfunction in HIV infected individuals in the era of
effective antiretroviral therapy may be, in part, secondary to the failure of current
antiretroviral regimens to eradicate the pool of HIV-infected and activated monocytes within
the bloodstream. Trafficking of such HIV infected and activated blood monocytes into the
brain parenchyma is believed to introduce HIV into the brain and precipitate immune
activation and inflammation, ultimately leading to neuronal degeneration.
Ferumoxytol is an ultrasmall superparamagnetic iron-oxide (USPIO), which is FDA-approved for
intravenous iron-replacement therapy in anemic patients with chronic kidney disease. The
paramagnetic properties of ferumoxytol also allow it to be used as a MRI contrast agent.
Ferumoxytol is avidly taken up by circulating monocytes and reactive astrocytes, microglia,
and dendritic cells within the brain, making it potentially a novel biomarker for
HIV-associated cognitive impairment given the role of monocytes in its pathogenesis.
This proposal intends to investigate the possible use of ferumoxytol (a new MRI contrast
agent) as a biomarker for HIV-associated cognitive impairment and to assess the safety and
tolerability of ferumoxytol in HIV-infected individuals.
Hypotheses to be tested:
- HIV-infected subjects with undetectable plasma HIV RNA levels and detectable levels of
HIV DNA in CD14+ peripheral blood mononuclear cells (PBMCs) and impairment on
neurocognitive testing will demonstrate ferumoxytol contrast enhancement in the
perivascular regions of the brain consistent with monocyte/macrophage infiltration in
these regions.
- Ferumoxytol can be safely administered to HIV-infected subjects.
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