Trial record 31 of 126 for: "Viral Infectious Disease" | "Ethanol"
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
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|ClinicalTrials.gov Identifier: NCT04050735|
Recruitment Status : Not yet recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection Alcohol Drinking||Other: Alcohol, ethyl, moderate dose Other: Placebo||Phase 2|
A sample of 56 participants, to include equal numbers of PLWH 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2022|
Experimental: Alcohol, ethyl, moderate dose
0.6 gram ethyl alcohol per kilogram of body weight
Other: Alcohol, ethyl, moderate dose
Moderate oral dose of ethyl alcohol
Placebo Comparator: Placebo
0 gram ethyl alcohol per kilogram of body weight
Primary Outcome Measures :
- Plasma biomarker of microbial translocation [ Time Frame: 0-3 hours ]Lipopolysaccharide (LPS), measured in pg/ml
- Plasma biomarkers of immune activation [ Time Frame: 0-3 hours ]LPS binding protein (LBP), soluble cluster of differentiation 14 (sCD14), soluble cluster of differentiation 163 (sCD163), measured in ng/ml
- Cerebral metabolites [ Time Frame: 5 hours ]Magnetic resonance spectroscopy will be used quantify cerebral metabolites in brain regions of interest. Primary metabolites of interest include the summed peak of glutamate and glutamine; glutathione; and choline.
- White matter diffusivity [ Time Frame: 5 hours ]Diffusion-weighted MRI will be used to quantify diffusivity metrics in brain white matter. Primary outcomes are fractional anisotropy (measured on a scale of 0-1, where 1 reflects total anisotropy), axial diffusivity (parallel to the primary axis), radial diffusivity (perpendicular to the primary axis).
Secondary Outcome Measures :
- Subjective intoxication [ Time Frame: 0-5 hours ]Visual Analog Scale, where a higher rating indicates greater subjective feelings of alcohol intoxication
- Cognitive functioning [ Time Frame: 0-2 hours ]Repeatable Battery for Assessment of Neuropsychological Status standardized scores
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