Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 8:04 AM
Study NCT ID:
NCT04050735
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mollie_monnig@brown.edu', 'phone': '401-863-3491', 'title': 'Dr. Mollie Monnig', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "For the duration of a participants' participation (an average of three months from baseline to completion).", 'eventGroups': [{'id': 'EG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Biomarker of Microbial Translocation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'OG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'OG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'OG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '58.562', 'spread': '26.2243', 'groupId': 'OG000'}, {'value': '99.285', 'spread': '48.2314', 'groupId': 'OG001'}, {'value': '77.232', 'spread': '31.6189', 'groupId': 'OG002'}, {'value': '97.343', 'spread': '42.9950', 'groupId': 'OG003'}]}]}, {'title': 'Hour 1', 'categories': [{'measurements': [{'value': '52.421', 'spread': '18.2908', 'groupId': 'OG000'}, {'value': '91.230', 'spread': '45.7622', 'groupId': 'OG001'}, {'value': '81.651', 'spread': '31.7415', 'groupId': 'OG002'}, {'value': '98.079', 'spread': '47.9421', 'groupId': 'OG003'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '64.928', 'spread': '24.6054', 'groupId': 'OG000'}, {'value': '96.092', 'spread': '54.8184', 'groupId': 'OG001'}, {'value': '88.037', 'spread': '31.6958', 'groupId': 'OG002'}, {'value': '107.312', 'spread': '47.1446', 'groupId': 'OG003'}]}]}, {'title': 'Hour 3', 'categories': [{'measurements': [{'value': '66.267', 'spread': '25.6505', 'groupId': 'OG000'}, {'value': '94.090', 'spread': '50.1699', 'groupId': 'OG001'}, {'value': '67.979', 'spread': '14.8000', 'groupId': 'OG002'}, {'value': '95.877', 'spread': '50.5859', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.343', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'F-test', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.125', 'groupDescription': 'Linear mixed model testing the three-way interaction of HIV serostatus (positive/negative), beverage condition (alcohol/placebo), and time (hour 0, 1, 2, 3).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'None of the above apply to this study'}], 'paramType': 'MEAN', 'timeFrame': '0-3 hours', 'description': 'Lipopolysaccharide (LPS), measured in pg/ml', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Plasma Biomarkers of Immune Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'OG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'OG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'OG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '323.50', 'spread': '28.333', 'groupId': 'OG000'}, {'value': '301.22', 'spread': '94.120', 'groupId': 'OG001'}, {'value': '376.36', 'spread': '80.593', 'groupId': 'OG002'}, {'value': '271.79', 'spread': '85.204', 'groupId': 'OG003'}]}]}, {'title': 'Hour 1', 'categories': [{'measurements': [{'value': '261.77', 'spread': '41.248', 'groupId': 'OG000'}, {'value': '304.71', 'spread': '100.360', 'groupId': 'OG001'}, {'value': '412.88', 'spread': '95.823', 'groupId': 'OG002'}, {'value': '276.51', 'spread': '80.020', 'groupId': 'OG003'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '261.51', 'spread': '45.48', 'groupId': 'OG000'}, {'value': '298.80', 'spread': '107.154', 'groupId': 'OG001'}, {'value': '410.52', 'spread': '117.886', 'groupId': 'OG002'}, {'value': '262.46', 'spread': '87.451', 'groupId': 'OG003'}]}]}, {'title': 'Hour 3', 'categories': [{'measurements': [{'value': '303.82', 'spread': '43.385', 'groupId': 'OG000'}, {'value': '300.68', 'spread': '105.172', 'groupId': 'OG001'}, {'value': '405.28', 'spread': '111.696', 'groupId': 'OG002'}, {'value': '275.30', 'spread': '82.670', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.026', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'F-test', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.236', 'groupDescription': 'Linear mixed model testing the three-way interaction of HIV serostatus (positive/negative), beverage condition (alcohol/placebo), and time (hour 0, 1, 2, 3).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'None of the above options apply to this study.'}], 'paramType': 'MEAN', 'timeFrame': '0-3 hours', 'description': 'soluble cluster of differentiation 163 (sCD163), measured in ng/ml', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cerebral Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'OG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'OG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'OG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'classes': [{'title': 'Glutamate+glutamine', 'categories': [{'measurements': [{'value': '13.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '14.4', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': 'Choline', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '1.75', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.33', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.987', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'The p-value for the interaction of HIV serostatus by beverage condition.', 'groupDescription': 'Test of group by condition interaction on choline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The above categories do not apply to this type of study.'}, {'pValue': '.836', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Test of group by condition interaction on summed peak of glutamate plus glutamine', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The above types of tests do not apply to this study.'}], 'paramType': 'MEAN', 'timeFrame': '5 hours', 'description': '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.', 'unitOfMeasure': 'mmol/kg of tissue water', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One participant's data was lost due to computational/technical factors."}, {'type': 'PRIMARY', 'title': 'White Matter Diffusivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'OG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'OG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'OG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'classes': [{'categories': [{'measurements': [{'value': '.560', 'spread': '.011', 'groupId': 'OG000'}, {'value': '.570', 'spread': '.009', 'groupId': 'OG001'}, {'value': '.562', 'spread': '.007', 'groupId': 'OG002'}, {'value': '.574', 'spread': '.009', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.846', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Test of group by condition interaction on fractional anisotropy (FA).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The above types of tests do not apply to this study.'}], 'paramType': 'MEAN', 'timeFrame': '5 hours', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants were lost to analysis due to technical/computational reasons.'}, {'type': 'SECONDARY', 'title': 'Subjective Intoxication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'OG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'OG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'OG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '1.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.894', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Test of interaction of group by beverage condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The above types of tests do not apply to this study.'}], 'paramType': 'MEAN', 'timeFrame': '0-5 hours', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full sample'}, {'type': 'SECONDARY', 'title': 'Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'OG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'OG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'OG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'timeFrame': '0-2 hours', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV seropositive - placebo group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'FG001', 'title': 'HIV seronegative - placebo group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'FG002', 'title': 'HIV seropositive - alcohol group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'FG003', 'title': 'HIV seronegative - alcohol group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV Seropositive - Placebo Group', 'description': 'Individuals with confirmed HIV infection who received the placebo condition'}, {'id': 'BG001', 'title': 'HIV Seronegative - Placebo Group', 'description': 'Individuals confirmed negative for HIV infection who received the placebo condition'}, {'id': 'BG002', 'title': 'HIV Seropositive - Alcohol Group', 'description': 'Individuals with confirmed HIV infection who received the alcohol condition'}, {'id': 'BG003', 'title': 'HIV Seronegative - Alcohol Group', 'description': 'Individuals confirmed negative for HIV infection who received the alcohol condition'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '35.73', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '40.0', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '31.8', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '35.9', 'spread': '10.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-18', 'size': 66444, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-07T09:37', 'hasProtocol': True}, {'date': '2022-12-20', 'size': 133315, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-07T09:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2019-07-09', 'resultsFirstSubmitDate': '2025-10-07', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-02', 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Biomarker of Microbial Translocation', 'timeFrame': '0-3 hours', 'description': 'Lipopolysaccharide (LPS), measured in pg/ml'}, {'measure': 'Plasma Biomarkers of Immune Activation', 'timeFrame': '0-3 hours', 'description': 'soluble cluster of differentiation 163 (sCD163), measured in ng/ml'}, {'measure': 'Cerebral Metabolites', 'timeFrame': '5 hours', 'description': '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.'}, {'measure': 'White Matter Diffusivity', 'timeFrame': '5 hours', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Subjective Intoxication', 'timeFrame': '0-5 hours', 'description': '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.'}, {'measure': 'Cognitive Functioning', 'timeFrame': '0-2 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV infection', 'alcohol', 'brain', 'inflammation'], 'conditions': ['HIV-1-infection', 'Alcohol Drinking']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "General Inclusion Criteria:\n\n1. 21-60 years old;\n2. Able to speak and read English at least at 8th grade level;\n3. 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.\n4. Body mass index of 18.5-34.9 kg/m2;\n5. Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection;\n6. HIV-1 serostatus (positive or negative, depending on group) confirmed by standard clinical testing;\n7. Able to consume soy and nuts safely (in order to consume the standardized meal).\n\nGeneral Exclusion Criteria:\n\n1. 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;\n2. More than five heavy drinking episodes in past 90 days;\n3. Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation treatment;\n4. Antibiotic use in past 1 month;\n5. Daily use of non-steroidal anti-inflammatory drugs, which are known to increase gut permeability;\n6. Disorder of the lower GI tract (e.g., inflammatory bowel disease, ulcerative colitis);\n7. Positive urine test for amphetamine, cocaine, methamphetamine, opioids, or benzodiazepines (cannabis use will be assessed but is not an exclusion criterion);\n8. Positive screening for past 12-month drug use disorder, indicated by Drug Abuse Screening Test-10 score \\>2;\n9. Current major psychiatric disorder (current major depressive episode, bipolar disorder, psychotic disorder);\n10. History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;\n11. 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;\n12. Head trauma with loss of consciousness \\>10 min;\n13. Inability to abstain from nicotine for 8 hours in-session;\n14. For cannabis users: inability to abstain for 48 hours prior to study;\n15. Pregnant, breastfeeding, or not using effective birth control;\n16. 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.\n\nHIV-Specific Inclusion Criteria:\n\n1. On antiretroviral therapy (ART) for ≥6 mos;\n2. 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;\n3. No active AIDS diagnosis."}, 'identificationModule': {'nctId': 'NCT04050735', 'briefTitle': 'Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection', 'orgStudyIdInfo': {'id': '1904002429'}, 'secondaryIdInfos': [{'id': 'P20GM130414', 'link': 'https://reporter.nih.gov/quickSearch/P20GM130414', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol, ethyl, moderate dose', 'description': '0.6 gram ethyl alcohol per kilogram of body weight', 'interventionNames': ['Other: Alcohol, ethyl, moderate dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0 gram ethyl alcohol per kilogram of body weight', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Alcohol, ethyl, moderate dose', 'type': 'OTHER', 'description': 'Moderate oral dose of ethyl alcohol', 'armGroupLabels': ['Alcohol, ethyl, moderate dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo beverage', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University and The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Mollie Monnig, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'Individual-level data will be available after papers are accepted for publication.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Institutions and individuals wishing to access data must contact the Principal Investigator (Peter Monti, PhD). Persons requesting data must do so in writing, identifying the affiliation and how the data will be used. Co-authorship is not required as a condition for receiving data. Users will agree that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. Requestors will be required to sign a data and biospecimen sharing agreement with further stipulations for data use and security.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, {'name': 'The Miriam Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}