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Moderate drinking may worsen HIV brain inflammation, study finds

NCT ID NCT04050735

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how moderate alcohol use affects inflammation and brain health in people with HIV. Researchers gave controlled amounts of alcohol to 76 healthy volunteers and people with HIV, then used blood tests and brain scans to measure immune and brain changes. The goal was to better understand the risks of alcohol in HIV, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

76 people

The number who actually took part.

Started

May 2021

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General 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). General 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. HIV-Specific Inclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking HIV infectious disease Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brown University and The Miriam Hospital

    Providence, Rhode Island, 02912, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.