Brown University and The Miriam Hospital
Providence, Rhode Island, 02912, United States
NCT Number: NCT04050735
This study will examine whether moderate alcohol use in the context of HIV infection exacerbates inflammatory signaling in the immune system and brain. The study will recruit healthy individuals and people living with HIV infection who are otherwise in good health to participate. Participants will complete an experimental protocol that involves controlled alcohol administration and magnetic resonance imaging (MRI). Primary outcomes are plasma biomarkers of inflammation and MRI markers correlated with neuroinflammation. Results will advance understanding of the effects of alcohol use in people living with HIV infection.
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Notify Me21 year–60 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02912, United States
A sample of 56 participants, to include equal numbers of people living with HIV and uninfected controls, will be recruited to complete the experimental protocol. Participants will be randomized to one of the two beverage conditions (0.60 g/kg alcohol beverage, 0.00 g/kg placebo beverage). Blood samples will be collected at baseline (prior to beverage administration) and for three hours afterward. Cognitive performance and subjective intoxication will be assessed using standardized measures. MRI scans will be collected 4-5 hours after beverage consumption to capture neurobiological outcomes on the descending limb of blood alcohol.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
General Inclusion Criteria:
General Exclusion Criteria:
HIV-Specific Inclusion Criteria:
Moderate oral dose of ethyl alcohol
Placebo beverage
Time frame: 0-3 hours
Lipopolysaccharide (LPS), measured in pg/ml
Time frame: 0-3 hours
soluble cluster of differentiation 163 (sCD163), measured in ng/ml
Time frame: 5 hours
Magnetic resonance spectroscopy will be used quantify cerebral metabolites in brain regions of interest, specifically frontal lobe. Primary metabolites of interest include the summed peak of glutamate and glutamine; choline.
Time frame: 5 hours
Diffusion-weighted MRI will be used to quantify diffusivity metrics in brain white matter. Primary outcome is fractional anisotropy (measured on a scale of 0-1, where 1 reflects total anisotropy).
Time frame: 0-5 hours
Intoxication rating scale (0-10), where a higher rating indicates greater subjective feelings of alcohol intoxication. Participants rate their maximum level of intoxication during the study.
Time frame: 0-2 hours
Repeatable Battery for Assessment of Neuropsychological Status standardized scores; Note: this measure was unable to be administered to due coronavirus (COVID-19) pandemic restrictions related to social distancing.
Brown University
Other
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