Moderate drinking may worsen HIV brain inflammation, study finds
NCT ID NCT04050735
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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76 people
The number who actually took part.
- Started
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May 2021
- Finished
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Jul 2024
- Lead sponsor
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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
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21 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brown University and The Miriam Hospital
Providence, Rhode Island, 02912, United States
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Other studies related to the condition(s) this trial covers.
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