HIV-1-infectionNCT04050735
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
A study testing Alcohol, ethyl, moderate dose in people with HIV-1-infection and Alcohol Drinking, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Alcohol Drinking
- What is being tested?
- Alcohol, ethyl, moderate dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
General Inclusion Criteria:
- 21-60 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).
General Exclusion Criteria:
- 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 urine test for amphetamine, cocaine, methamphetamine, opioids, or benzodiazepines (cannabis use will be assessed but is not an exclusion criterion);
- 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.
HIV-Specific Inclusion Criteria:
- On antiretroviral therapy (ART) for ≥6 mos;
- 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;
- No active AIDS diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University and The Miriam Hospital
Providence, Rhode Island, 02912
About this study
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.
Read the 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
- Being tested
- Alcohol, ethyl, moderate dose, Placebo
- Keywords
- HIV infection, alcohol, brain, inflammation
- Medical subject headings
- Alcohol Drinking, HIV Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol, ethyl, moderate doseOther
Moderate oral dose of ethyl alcohol
PlaceboOther
Placebo beverage
| Study group | Role | What they receive |
|---|---|---|
| Alcohol, ethyl, moderate dose | Experimental | 0.6 gram ethyl alcohol per kilogram of body weight Receives: Other: Alcohol, ethyl, moderate dose |
| Placebo | Placebo comparator | 0 gram ethyl alcohol per kilogram of body weight Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Biomarker of Microbial Translocation
Lipopolysaccharide (LPS), measured in pg/ml
Measured: 0-3 hours
Plasma Biomarkers of Immune Activation
soluble cluster of differentiation 163 (sCD163), measured in ng/ml
Measured: 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.
Measured: 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).
Measured: 5 hours
Secondary outcomes (2)
Subjective Intoxication
Intoxication rating scale (0-10), where a higher rating indicates greater subjective feelings of alcohol intoxication. Participants rate their maximum level of intoxication during the study.
Measured: 0-5 hours
Cognitive Functioning
Repeatable Battery for Assessment of Neuropsychological Status standardized scores; Note: this measure was unable to be administered to due coronavirus (COVID-19) pandemic restrictions related to social distancing.
Measured: 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start19 May 2021
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), The Miriam Hospital
- Responsible party
- Sponsor
- Investigators
- Mollie Monnig, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050735
- Sponsor's protocol ID
- 1904002429
- Other IDs
- P20GM130414
- Status last verified
- Oct 2024
- First submitted
- 9 Jul 2019
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated by this study will be made available to outside investigators in accordance with NIH guidance and policies on data sharing. Data will be available in summary form and as raw individual-level data for analysis.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
- ClinicalTrials.gov ID
- NCT04050735
- Acronym / sponsor ID
- 1904002429
- Conditions
- HIV-1-infection, Alcohol Drinking
- Keywords
- HIV infection, alcohol, brain, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), The Miriam Hospital
- Study start
- 19 May 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol, ethyl, moderate dose | Experimental | Other: Alcohol, ethyl, moderate dose0.6 gram ethyl alcohol per kilogram of body weight |
| Placebo | Placebo comparator | Other: Placebo0 gram ethyl alcohol per kilogram of body weight |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol, ethyl, moderate doseModerate oral dose of ethyl alcohol | Other | Alcohol, ethyl, moderate dose |
| PlaceboPlacebo beverage | Other | Placebo |
Primary outcome
Plasma Biomarker of Microbial Translocation
Time frame: 0-3 hours
Lipopolysaccharide (LPS), measured in pg/ml
Plasma Biomarkers of Immune Activation
Time frame: 0-3 hours
soluble cluster of differentiation 163 (sCD163), measured in ng/ml
Cerebral Metabolites
Time frame: 5 hours
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.
White Matter Diffusivity
Time frame: 5 hours
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).
2 secondary outcomes
Subjective Intoxication
Time frame: 0-5 hours
Cognitive Functioning
Time frame: 0-2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data generated by this study will be made available to outside investigators in accordance with NIH guidance and policies on data sharing. Data will be available in summary form and as raw individual-level data for analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mollie Monnig, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol, ethyl, moderate dose in people with HIV-1-infection and Alcohol Drinking, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Biomarker of Microbial Translocation (time frame: 0-3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.