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

NCT ID: NCT04050735

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2024-07-02

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 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.

Conditions

HIV-1-infection; Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Alcohol, ethyl, moderate dose

0.6 gram ethyl alcohol per kilogram of body weight

Group Type: EXPERIMENTAL

Alcohol, ethyl, moderate dose

Intervention Type: OTHER

Moderate oral dose of ethyl alcohol

Placebo

0 gram ethyl alcohol per kilogram of body weight

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo beverage

Interventions

Alcohol, ethyl, moderate dose

Moderate oral dose of ethyl alcohol

Intervention Type: OTHER

Placebo

Placebo beverage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 21-60 years old;

2. Able to speak and read English at least at 8th grade level;

3. 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.

4. Body mass index of 18.5-34.9 kg/m2;

5. Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection;

6. HIV-1 serostatus (positive or negative, depending on group) confirmed by standard clinical testing;

7. Able to consume soy and nuts safely (in order to consume the standardized meal).

1. On antiretroviral therapy (ART) for ≥6 mos;

2. Labs in past 6 mos showing viral load <100 copies/mL, hemoglobin ≥10.0 g/dL, neutrophil count ≥1,000 cells/μL, and platelet count ≥150,000/μL;

3. No active AIDS diagnosis.

Exclusion Criteria

1. 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;

2. More than five heavy drinking episodes in past 90 days;

3. Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation treatment;

4. Antibiotic use in past 1 month;

5. Daily use of non-steroidal anti-inflammatory drugs, which are known to increase gut permeability;

6. Disorder of the lower GI tract (e.g., inflammatory bowel disease, ulcerative colitis);

7. Positive urine test for amphetamine, cocaine, methamphetamine, opioids, or benzodiazepines (cannabis use will be assessed but is not an exclusion criterion);

8. Positive screening for past 12-month drug use disorder, indicated by Drug Abuse Screening Test-10 score >2;

9. Current major psychiatric disorder (current major depressive episode, bipolar disorder, psychotic disorder);

10. History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;

11. 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;

12. Head trauma with loss of consciousness >10 min;

13. Inability to abstain from nicotine for 8 hours in-session;

14. For cannabis users: inability to abstain for 48 hours prior to study;

15. Pregnant, breastfeeding, or not using effective birth control;

16. 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mollie Monnig, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University and The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P20GM130414

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1904002429

Identifier Type: -

Identifier Source: org_study_id