Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection

Not Applicable

Completed

• Conditions: Alcohol Drinking; HIV-1-infection
• Interventions: Other: Placebo; Other: Alcohol, ethyl, moderate dose

• Registration Number: NCT04050735
• Lead Sponsor: Brown University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2021-05-19
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• 21 to 60 years of age
• able to speak and read English at least at 8th grade level
• alcohol use as defined by study protocol
• body mass index of 18.5-30 kg/m2
• Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection
• HIV-1 serostatus confirmed by standard clinical testing
• HIV-specific criteria for antiretroviral medication use and lab parameters
• Able to consume soy and nuts safely

Exclusion Criteria

• heavy drinking as defined by study protocol
• treatment for alcohol/drug use, with exception of smoking cessation
• use of specific medications in the past month
• daily use of specific over-the-counter drugs
• disorder of the lower GI tract
• positive urine drug test or screening for drug use disorder
• current major psychiatric disorder
• history of significant problems from blood draw
• safety contraindication for MRI
• head trauma with loss of consciousness > 10 min
• inability to abstain from nicotine during study session
• inability to abstain from cannabis before and during study session
• pregnant, breastfeeding, or not using effective birth control
• any other clinical condition or therapy that, in the physician's opinion, would make the individual unsuitable for study or unable to comply with dosing requirement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0 gram ethyl alcohol per kilogram of body weight
Alcohol, ethyl, moderate dose	Alcohol, ethyl, moderate dose	0.6 gram ethyl alcohol per kilogram of body weight

Primary Outcome Measures

Name	Time	Method
Cerebral metabolites	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	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).
Plasma biomarkers of immune activation	0-3 hours	LPS binding protein (LBP), soluble cluster of differentiation 14 (sCD14), soluble cluster of differentiation 163 (sCD163), measured in ng/ml
Plasma biomarker of microbial translocation	0-3 hours	Lipopolysaccharide (LPS), measured in pg/ml

Secondary Outcome Measures

Name	Time	Method
Cognitive functioning	0-2 hours	Repeatable Battery for Assessment of Neuropsychological Status standardized scores
Subjective intoxication	0-5 hours	Visual Analog Scale, where a higher rating indicates greater subjective feelings of alcohol intoxication

Trial Locations

Locations (1)

Brown University and The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States