NCT04050735 is a NA clinical trial of Alcohol, ethyl, moderate dose in HIV-1-infection, sponsored by Brown University.

Who is sponsoring NCT04050735?

NCT04050735 is sponsored by Brown University.

What drugs are being tested in NCT04050735?

Interventions in NCT04050735: Alcohol, ethyl, moderate dose, Placebo.

What condition does NCT04050735 study?

NCT04050735 studies HIV-1-infection, Alcohol Drinking.

Is NCT04050735 still recruiting?

NCT04050735 is currently completed. Last updated 17 December 2025.

Are results published for NCT04050735?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-12-17 · How we verify

NCT04050735

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 17 December 2025

What this trial tests

NA trial testing Alcohol, ethyl, moderate dose in HIV-1-infection in 76 participants. Completed in 2 July 2024.

Timeline

19 May 2021

Primary endpoint
2 July 2024

2 July 2024

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	76
Start date	19 May 2021
Primary completion	2 July 2024
Estimated completion	2 July 2024
Sites	1 location across United States

Drugs / interventions tested

Alcohol, ethyl, moderate dose
Placebo

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →
Alcohol Drinking — all drugs for Alcohol Drinking →

Sponsor

Brown University

Who can join

Adults 21 to 60, any sex, with HIV-1-infection or Alcohol Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Plasma Biomarker of Microbial Translocation Primary · 0-3 hours

Lipopolysaccharide (LPS), measured in pg/ml

Hour 0

Group	Value	95% CI
HIV seropositive - placebo group	58.562	± 26.2243
HIV seronegative - placebo group	99.285	± 48.2314
HIV seropositive - alcohol group	77.232	± 31.6189
HIV seronegative - alcohol group	97.343	± 42.9950

Hour 1

Group	Value	95% CI
HIV seropositive - placebo group	52.421	± 18.2908
HIV seronegative - placebo group	91.230	± 45.7622
HIV seropositive - alcohol group	81.651	± 31.7415
HIV seronegative - alcohol group	98.079	± 47.9421

Hour 2

Group	Value	95% CI
HIV seropositive - placebo group	64.928	± 24.6054
HIV seronegative - placebo group	96.092	± 54.8184
HIV seropositive - alcohol group	88.037	± 31.6958
HIV seronegative - alcohol group	107.312	± 47.1446

Hour 3

Group	Value	95% CI
HIV seropositive - placebo group	66.267	± 25.6505
HIV seronegative - placebo group	94.090	± 50.1699
HIV seropositive - alcohol group	67.979	± 14.8000
HIV seronegative - alcohol group	95.877	± 50.5859

Plasma Biomarkers of Immune Activation Primary · 0-3 hours

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

Hour 0

Group	Value	95% CI
HIV seropositive - placebo group	323.50	± 28.333
HIV seronegative - placebo group	301.22	± 94.120
HIV seropositive - alcohol group	376.36	± 80.593
HIV seronegative - alcohol group	271.79	± 85.204

Hour 1

Group	Value	95% CI
HIV seropositive - placebo group	261.77	± 41.248
HIV seronegative - placebo group	304.71	± 100.360
HIV seropositive - alcohol group	412.88	± 95.823
HIV seronegative - alcohol group	276.51	± 80.020

Hour 2

Group	Value	95% CI
HIV seropositive - placebo group	261.51	± 45.48
HIV seronegative - placebo group	298.80	± 107.154
HIV seropositive - alcohol group	410.52	± 117.886
HIV seronegative - alcohol group	262.46	± 87.451

Hour 3

Group	Value	95% CI
HIV seropositive - placebo group	303.82	± 43.385
HIV seronegative - placebo group	300.68	± 105.172
HIV seropositive - alcohol group	405.28	± 111.696
HIV seronegative - alcohol group	275.30	± 82.670

Cerebral Metabolites Primary · 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.

Glutamate+glutamine

Group	Value	95% CI
HIV seropositive - placebo group	13.0	± 1.5
HIV seronegative - placebo group	14.6	± 5.0
HIV seropositive - alcohol group	12.3	± 2.8
HIV seronegative - alcohol group	14.4	± 3.2

Choline

Group	Value	95% CI
HIV seropositive - placebo group	1.9	± 0.29
HIV seronegative - placebo group	1.8	± 0.38
HIV seropositive - alcohol group	1.75	± 0.22
HIV seronegative - alcohol group	1.7	± 0.33

White Matter Diffusivity Primary · 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).

Group	Value	95% CI
HIV seropositive - placebo group	.560	± .011
HIV seronegative - placebo group	.570	± .009
HIV seropositive - alcohol group	.562	± .007
HIV seronegative - alcohol group	.574	± .009

Subjective Intoxication Secondary · 0-5 hours

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.

Group	Value	95% CI
HIV seropositive - placebo group	1.6	± 2.1
HIV seronegative - placebo group	1.3	± 1.5
HIV seropositive - alcohol group	6.0	± 1.5
HIV seronegative - alcohol group	5.5	± 1.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Brown University trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04050735 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brown University
Last refreshed: 17 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04050735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing