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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04050735
• Other study ID #: 1904002429
• Secondary ID: P20GM130414
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: Brown University
• Contact: Research Assistant
• Phone: 4018636679
• Email: idresearch[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Drinking
• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Infections

Intervention

Other:
• Alcohol, ethyl, moderate dose
Moderate oral dose of ethyl alcohol
• Placebo
Placebo beverage

Locations

Country	Name	City	State
United States	Brown University and The Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	National Institute of General Medical Sciences (NIGMS), The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma biomarker of microbial translocation	Lipopolysaccharide (LPS), measured in pg/ml	0-3 hours
Primary	Plasma biomarkers of immune activation	LPS binding protein (LBP), soluble cluster of differentiation 14 (sCD14), soluble cluster of differentiation 163 (sCD163), measured in ng/ml	0-3 hours
Primary	Cerebral metabolites	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.	5 hours
Primary	White matter diffusivity	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).	5 hours
Secondary	Subjective intoxication	Visual Analog Scale, where a higher rating indicates greater subjective feelings of alcohol intoxication	0-5 hours
Secondary	Cognitive functioning	Repeatable Battery for Assessment of Neuropsychological Status standardized scores	0-2 hours