Trial Outcomes & Findings for Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection (NCT NCT04050735)

Last Updated: 2025-12-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

5 hours

Results posted on

2025-12-17

Participant Flow

Participants were recruited via online platforms (e.g., social media) and from The Miriam Hospital Infectious Diseases and Immunology Center, the largest outpatient provider of infectious disease treatment in Rhode Island.

Participants are considered "enrolled" when they provide informed consent for initial screening. However, there is a further eligibility assessment at which participants may be found ineligible for a variety of reasons. Therefore the total number of individuals completing the study is lower than the number of individuals enrolled.

Participant milestones

Participant milestones
Measure	HIV seropositive - placebo group Individuals with confirmed HIV infection who received the placebo condition	HIV seronegative - placebo group Individuals confirmed negative for HIV infection who received the placebo condition	HIV seropositive - alcohol group Individuals with confirmed HIV infection who received the alcohol condition	HIV seronegative - alcohol group Individuals confirmed negative for HIV infection who received the alcohol condition
Overall Study STARTED	5	15	6	12
Overall Study COMPLETED	5	15	6	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV Seropositive - Placebo Group n=5 Participants Individuals with confirmed HIV infection who received the placebo condition	HIV Seronegative - Placebo Group n=15 Participants Individuals confirmed negative for HIV infection who received the placebo condition	HIV Seropositive - Alcohol Group n=6 Participants Individuals with confirmed HIV infection who received the alcohol condition	HIV Seronegative - Alcohol Group n=12 Participants Individuals confirmed negative for HIV infection who received the alcohol condition	Total n=38 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 11.1 • n=6 Participants	35.73 years STANDARD_DEVIATION 11.1 • n=5 Participants	40.0 years STANDARD_DEVIATION 12.3 • n=5 Participants	31.8 years STANDARD_DEVIATION 9.4 • n=122 Participants	35.9 years STANDARD_DEVIATION 10.9 • n=488 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	8 Participants n=5 Participants	0 Participants n=5 Participants	5 Participants n=122 Participants	13 Participants n=488 Participants
Sex: Female, Male Male	5 Participants n=6 Participants	7 Participants n=5 Participants	6 Participants n=5 Participants	7 Participants n=122 Participants	25 Participants n=488 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=6 Participants	0 Participants n=5 Participants	2 Participants n=5 Participants	5 Participants n=122 Participants	9 Participants n=488 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=6 Participants	15 Participants n=5 Participants	4 Participants n=5 Participants	7 Participants n=122 Participants	29 Participants n=488 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants
Race (NIH/OMB) Asian	1 Participants n=6 Participants	2 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=122 Participants	5 Participants n=488 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants	2 Participants n=488 Participants
Race (NIH/OMB) White	3 Participants n=6 Participants	10 Participants n=5 Participants	4 Participants n=5 Participants	7 Participants n=122 Participants	24 Participants n=488 Participants
Race (NIH/OMB) More than one race	1 Participants n=6 Participants	2 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=122 Participants	5 Participants n=488 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=122 Participants	2 Participants n=488 Participants
Region of Enrollment United States	5 participants n=6 Participants	15 participants n=5 Participants	6 participants n=5 Participants	12 participants n=122 Participants	38 participants n=488 Participants

PRIMARY outcome

Timeframe: 0-3 hours

Population: Data from one participant in the "HIV seronegative - alcohol group" arm was not returned from the analytic laboratory and so this group had 11 rather than 12 participants for the LPS analysis.

Lipopolysaccharide (LPS), measured in pg/ml

Outcome measures

Outcome measures
Measure	HIV seropositive - placebo group n=5 Participants Individuals with confirmed HIV infection who received the placebo condition	HIV seronegative - placebo group n=15 Participants Individuals confirmed negative for HIV infection who received the placebo condition	HIV seropositive - alcohol group n=6 Participants Individuals with confirmed HIV infection who received the alcohol condition	HIV seronegative - alcohol group n=11 Participants Individuals confirmed negative for HIV infection who received the alcohol condition
Plasma Biomarker of Microbial Translocation Hour 0	58.562 pg/ml Standard Deviation 26.2243	99.285 pg/ml Standard Deviation 48.2314	77.232 pg/ml Standard Deviation 31.6189	97.343 pg/ml Standard Deviation 42.9950
Plasma Biomarker of Microbial Translocation Hour 1	52.421 pg/ml Standard Deviation 18.2908	91.230 pg/ml Standard Deviation 45.7622	81.651 pg/ml Standard Deviation 31.7415	98.079 pg/ml Standard Deviation 47.9421
Plasma Biomarker of Microbial Translocation Hour 2	64.928 pg/ml Standard Deviation 24.6054	96.092 pg/ml Standard Deviation 54.8184	88.037 pg/ml Standard Deviation 31.6958	107.312 pg/ml Standard Deviation 47.1446
Plasma Biomarker of Microbial Translocation Hour 3	66.267 pg/ml Standard Deviation 25.6505	94.090 pg/ml Standard Deviation 50.1699	67.979 pg/ml Standard Deviation 14.8000	95.877 pg/ml Standard Deviation 50.5859

PRIMARY outcome

Timeframe: 0-3 hours

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

Outcome measures

Outcome measures
Measure	HIV seropositive - placebo group n=5 Participants Individuals with confirmed HIV infection who received the placebo condition	HIV seronegative - placebo group n=15 Participants Individuals confirmed negative for HIV infection who received the placebo condition	HIV seropositive - alcohol group n=6 Participants Individuals with confirmed HIV infection who received the alcohol condition	HIV seronegative - alcohol group n=12 Participants Individuals confirmed negative for HIV infection who received the alcohol condition
Plasma Biomarkers of Immune Activation Hour 1	261.77 ng/ml Standard Deviation 41.248	304.71 ng/ml Standard Deviation 100.360	412.88 ng/ml Standard Deviation 95.823	276.51 ng/ml Standard Deviation 80.020
Plasma Biomarkers of Immune Activation Hour 2	261.51 ng/ml Standard Deviation 45.48	298.80 ng/ml Standard Deviation 107.154	410.52 ng/ml Standard Deviation 117.886	262.46 ng/ml Standard Deviation 87.451
Plasma Biomarkers of Immune Activation Hour 3	303.82 ng/ml Standard Deviation 43.385	300.68 ng/ml Standard Deviation 105.172	405.28 ng/ml Standard Deviation 111.696	275.30 ng/ml Standard Deviation 82.670
Plasma Biomarkers of Immune Activation Hour 0	323.50 ng/ml Standard Deviation 28.333	301.22 ng/ml Standard Deviation 94.120	376.36 ng/ml Standard Deviation 80.593	271.79 ng/ml Standard Deviation 85.204

PRIMARY outcome

Timeframe: 5 hours

Population: One participant's data was lost due to computational/technical factors.

Outcome measures

Outcome measures
Measure	HIV seropositive - placebo group n=5 Participants Individuals with confirmed HIV infection who received the placebo condition	HIV seronegative - placebo group n=14 Participants Individuals confirmed negative for HIV infection who received the placebo condition	HIV seropositive - alcohol group n=5 Participants Individuals with confirmed HIV infection who received the alcohol condition	HIV seronegative - alcohol group n=12 Participants Individuals confirmed negative for HIV infection who received the alcohol condition
Cerebral Metabolites Glutamate+glutamine	13.0 mmol/kg of tissue water Standard Deviation 1.5	14.6 mmol/kg of tissue water Standard Deviation 5.0	12.3 mmol/kg of tissue water Standard Deviation 2.8	14.4 mmol/kg of tissue water Standard Deviation 3.2
Cerebral Metabolites Choline	1.9 mmol/kg of tissue water Standard Deviation 0.29	1.8 mmol/kg of tissue water Standard Deviation 0.38	1.75 mmol/kg of tissue water Standard Deviation 0.22	1.7 mmol/kg of tissue water Standard Deviation 0.33

PRIMARY outcome

Timeframe: 5 hours

Population: 2 participants were lost to analysis due to technical/computational reasons.

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).

Outcome measures

Outcome measures
Measure	HIV seropositive - placebo group n=5 Participants Individuals with confirmed HIV infection who received the placebo condition	HIV seronegative - placebo group n=14 Participants Individuals confirmed negative for HIV infection who received the placebo condition	HIV seropositive - alcohol group n=5 Participants Individuals with confirmed HIV infection who received the alcohol condition	HIV seronegative - alcohol group n=12 Participants Individuals confirmed negative for HIV infection who received the alcohol condition
White Matter Diffusivity	.560 units on a scale Standard Deviation .011	.570 units on a scale Standard Deviation .009	.562 units on a scale Standard Deviation .007	.574 units on a scale Standard Deviation .009

SECONDARY outcome

Timeframe: 0-5 hours

Population: Full sample

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.

Outcome measures

Outcome measures
Measure	HIV seropositive - placebo group n=5 Participants Individuals with confirmed HIV infection who received the placebo condition	HIV seronegative - placebo group n=15 Participants Individuals confirmed negative for HIV infection who received the placebo condition	HIV seropositive - alcohol group n=6 Participants Individuals with confirmed HIV infection who received the alcohol condition	HIV seronegative - alcohol group n=12 Participants Individuals confirmed negative for HIV infection who received the alcohol condition
Subjective Intoxication	1.6 score on a scale Standard Deviation 2.1	1.3 score on a scale Standard Deviation 1.5	6.0 score on a scale Standard Deviation 1.5	5.5 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 0-2 hours

Population: Data cannot be reported because this test was not performed. Due to restrictions on human subjects research implemented during the COVID-19 pandemic, researchers were not allowed in the same room as participants for \>15 mins total during visits. This test (RBANS) was standardized with the administrator seated at a table across from the test taker. The test takes 20-30 mins to administer. Thus, due to COVID-19 rules, this test could not be administered as standardized.

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.

Outcome measures

Outcome data not reported

Adverse Events

HIV seropositive - placebo group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV seronegative - placebo group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV seropositive - alcohol group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV seronegative - alcohol group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mollie Monnig

Brown University

Phone: 401-863-3491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place