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

NCT04050735 | Completed Results

• 2 other identifiers: 1904002429P20GM130414
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection; Alcohol Drinking

Keywords

HIV infection; alcohol; brain; inflammation

Outcome Measures

Primary Outcomes (4)

• Plasma Biomarker of Microbial Translocation

  Lipopolysaccharide (LPS), measured in pg/ml

  0-3 hours

• Plasma Biomarkers of Immune Activation

  soluble cluster of differentiation 163 (sCD163), measured in ng/ml

  0-3 hours

• Cerebral Metabolites

  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.

  5 hours

• White Matter Diffusivity

  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).

  5 hours

Secondary Outcomes (2)

• Subjective Intoxication

  0-5 hours

• Cognitive Functioning

  0-2 hours

Study Arms (2)

Alcohol, ethyl, moderate dose

EXPERIMENTAL

0.6 gram ethyl alcohol per kilogram of body weight

Other: Alcohol, ethyl, moderate dose

Placebo

PLACEBO COMPARATOR

0 gram ethyl alcohol per kilogram of body weight

Other: Placebo

Interventions

Alcohol, ethyl, moderate dose OTHER

Moderate oral dose of ethyl alcohol

Alcohol, ethyl, moderate dose

Placebo OTHER

Placebo beverage

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• Able to speak and read English at least at 8th grade level;
• Alcohol use ≥.60 g/kg at least once in past year. In standard drinks, this amount translates to 1.9-3.0 drinks for an average-weight female and 2.4-3.9 drinks for an average-weight male.
• Body mass index of 18.5-34.9 kg/m2;
• Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection;
• HIV-1 serostatus (positive or negative, depending on group) confirmed by standard clinical testing;
• Able to consume soy and nuts safely (in order to consume the standardized meal).

You may not qualify if:

• History of heavy drinking on a weekly or more frequent basis, with heavy drinking defined per NIAAA guidelines (≥4 drinks for women, ≥5 drinks for men on a given day), in the past two years;
• More than five heavy drinking episodes in past 90 days;
• Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation treatment;
• Antibiotic use in past 1 month;
• Daily use of non-steroidal anti-inflammatory drugs, which are known to increase gut permeability;
• Disorder of the lower GI tract (e.g., inflammatory bowel disease, ulcerative colitis);
• Positive screening for past 12-month drug use disorder, indicated by Drug Abuse Screening Test-10 score \>2;
• Current major psychiatric disorder (current major depressive episode, bipolar disorder, psychotic disorder);
• History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
• Safety contraindication for MRI (e.g., metal implant); Note: copper intrauterine devices (IUDs) continue to be excluded due to Brown MRI research facility regulations but other non-metal IUDs are allowed;
• Head trauma with loss of consciousness \>10 min;
• Inability to abstain from nicotine for 8 hours in-session;
• For cannabis users: inability to abstain for 48 hours prior to study;
• Pregnant, breastfeeding, or not using effective birth control;
• Any other clinical condition or therapy that, in the physician's opinion, would make subject unsuitable for study or unable to comply with dosing requirement.

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• The Miriam Hospital: collaborator

Study Sites (1)

Brown University and The Miriam Hospital

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; HIV Infections; Inflammation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Mollie Monnig
• Organization: Brown University

mollie_monnig@brown.edu

401-863-3491

Study Officials

• Mollie Monnig, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: August 8, 2019
• Study Start: May 19, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Individual-level data will be available after papers are accepted for publication.
• Access Criteria: Institutions and individuals wishing to access data must contact the Principal Investigator (Peter Monti, PhD). Persons requesting data must do so in writing, identifying the affiliation and how the data will be used. Co-authorship is not required as a condition for receiving data. Users will agree that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. Requestors will be required to sign a data and biospecimen sharing agreement with further stipulations for data use and security.

Locations

US (1)