Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-06 @ 1:44 AM
Study NCT ID:
NCT02473367
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Periods 1-3: up to 24 hours after treatment with raltegravir; Period 4: up to 14 days after treatment with raltegravir', 'description': 'Participants who received at least one dose of raltegravir', 'eventGroups': [{'id': 'EG000', 'title': 'Period 1: Raltegravir Only', 'description': '1200 mg raltegravir, once at the start of Period 1', 'otherNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Period 2: Raltegravir + TUMS Concomitantly', 'description': '1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2', 'otherNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Period 3: Raltegravir + 12 Hrs Leader Antacid', 'description': '1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS', 'otherNumAtRisk': 19, 'otherNumAffected': 5, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Period 4: Raltegravir + 12 Hrs TUMS', 'description': '1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000', 'otherNumAtRisk': 19, 'otherNumAffected': 5, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: Raltegravir Only', 'description': '1200 mg raltegravir, once at the start of Period 1'}, {'id': 'OG001', 'title': 'Period 2: Raltegravir + TUMS Concomitantly', 'description': '1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2'}, {'id': 'OG002', 'title': 'Period 3: Raltegravir + 12 Hrs Leader Antacid', 'description': '1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS'}, {'id': 'OG003', 'title': 'Period 4: Raltegravir + 12 Hrs TUMS', 'description': '1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000'}], 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '65.2'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '17.7'}, {'value': '46.3', 'groupId': 'OG002', 'lowerLimit': '36.0', 'upperLimit': '59.6'}, {'value': '48.5', 'groupId': 'OG003', 'lowerLimit': '39.0', 'upperLimit': '60.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. least-squares mean ratio (GLSMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.28', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.32', 'estimateComment': 'Raltegravir+TUMS/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.03', 'estimateComment': 'Raltegravir+12 Hrs Leader Antacid/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.03', 'estimateComment': 'Raltegravir+12 Hrs TUMS/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.', 'unitOfMeasure': 'hr*µM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: Raltegravir Only', 'description': '1200 mg raltegravir, once at the start of Period 1'}, {'id': 'OG001', 'title': 'Period 2: Raltegravir + TUMS Concomitantly', 'description': '1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2'}, {'id': 'OG002', 'title': 'Period 3: Raltegravir + 12 Hrs Leader Antacid', 'description': '1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS'}, {'id': 'OG003', 'title': 'Period 4: Raltegravir + 12 Hrs TUMS', 'description': '1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000'}], 'classes': [{'categories': [{'measurements': [{'value': '20000', 'groupId': 'OG000', 'lowerLimit': '16500', 'upperLimit': '24300'}, {'value': '5240', 'groupId': 'OG001', 'lowerLimit': '4230', 'upperLimit': '6490'}, {'value': '17300', 'groupId': 'OG002', 'lowerLimit': '12800', 'upperLimit': '23300'}, {'value': '19500', 'groupId': 'OG003', 'lowerLimit': '15900', 'upperLimit': '24000'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.26', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.32', 'estimateComment': 'Raltegravir+TUMS/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.15', 'estimateComment': 'Raltegravir+12 Hrs Leader Antacid/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.17', 'estimateComment': 'Raltegravir+12 Hrs TUMS/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.', 'unitOfMeasure': 'nM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: Raltegravir Only', 'description': '1200 mg raltegravir, once at the start of Period 1'}, {'id': 'OG001', 'title': 'Period 2: Raltegravir + TUMS Concomitantly', 'description': '1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2'}, {'id': 'OG002', 'title': 'Period 3: Raltegravir + 12 Hrs Leader Antacid', 'description': '1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS'}, {'id': 'OG003', 'title': 'Period 4: Raltegravir + 12 Hrs TUMS', 'description': '1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '55.3', 'upperLimit': '103'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '52.5'}, {'value': '32.0', 'groupId': 'OG002', 'lowerLimit': '23.7', 'upperLimit': '43.2'}, {'value': '32.4', 'groupId': 'OG003', 'lowerLimit': '24.6', 'upperLimit': '42.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.52', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.61', 'estimateComment': 'Raltegravir+TUMS/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.42', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.52', 'estimateComment': 'Raltegravir+12 Hrs Leader Antacid/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'GLSMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.43', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.51', 'estimateComment': 'Raltegravir+12 Hrs TUMS/Raltegravir only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 hours post-dose', 'description': 'In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.', 'unitOfMeasure': 'nM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Four Period Fixed Sequence', 'description': 'All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Wait 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Wait 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Wait 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Males or females, at least 18 years of age, with HIV infection were enrolled in this trial.', 'preAssignmentDetails': 'Starting five days prior to Period 1 participants were treated with 1200 mg raltegravir (MK-0518), once daily for five days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Participants', 'description': 'All participants who enrolled in the study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2015-06-12', 'resultsFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2015-06-12', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-19', 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose', 'description': 'In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.'}, {'measure': 'Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir', 'timeFrame': '24 hours post-dose', 'description': 'In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '27671833', 'type': 'RESULT', 'citation': 'Krishna R, East L, Larson P, Valiathan C, Butterfield K, Teng Y, Hernandez-Illas M. Effect of metal-cation antacids on the pharmacokinetics of 1200 mg raltegravir. J Pharm Pharmacol. 2016 Nov;68(11):1359-1365. doi: 10.1111/jphp.12632. Epub 2016 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is HIV positive\n* Is on a stable raltegravir-containing (400 mg every 12hr) antiretroviral (ARV) regimen for at least 1 month prior to study entry, with no changes, including dose adjustments; and agrees to maintain their current ARV therapy throughout the study.\n* Be male, or a non-pregnant and non-breast feeding female at least 18 years of age at the pre-trial (screening)\n* Has a Body Mass Index (BMI) =\\< 32 kg/m\\^2\n\nExclusion Criteria:\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases (excluding HIV)\n* Has a history of gastric bypass surgery\n* Has a history of cancer (malignancy)\n* Has a history of chronic diarrhea within approximately 3 months prior to the pre-trial visit\n* Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n* Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-trial visit\n* Has participated in another investigational trial within 4 weeks prior to the pre-trial visit\n* Is currently taking rifampin or atazanavir or is unable to refrain from the use of 1) any proton pump inhibitor from two weeks prior to the study through the completion of Period 4, and 2) any H2-blockers, over-the-counter antacids, calcium supplements or multivitamins from one week prior to the study through the completion of Period 4\n* Consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day\n* Consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day\n* Is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months of screening'}, 'identificationModule': {'nctId': 'NCT02473367', 'briefTitle': 'The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Evaluate the Influence of Metal Cation-Containing Antacids on MK-0518 Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen', 'orgStudyIdInfo': {'id': '0518-824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raltegravir Pre- and 4 Period Sequence', 'description': 'Starting five days prior to Period 1 participants will be treated with 1200 mg raltegravir, once daily for five days. In Period 1 participants will be treated with 1200 raltegravir alone; this is followed by Period 2 where participants will be treated with 1200 mg raltegravir and TUMS concomitantly; this is followed by Period 3 where participants will be treated with 1200 mg raltegravir and 12 hours later with Leader Antacid; followed by Period 4 where participants will be treated with 1200 mg raltegravir and 12 hours later with TUMS. The wait between Periods is 2-7 days.', 'interventionNames': ['Drug: Raltegravir 1200 mg', 'Drug: TUMS', 'Drug: Leader Antacid']}], 'interventions': [{'name': 'Raltegravir 1200 mg', 'type': 'DRUG', 'description': 'Two tablets of 600 mg raltegravir administered orally, once daily, over 5 days of Pre-treatment, and once at the start of Periods 1-4.', 'armGroupLabels': ['Raltegravir Pre- and 4 Period Sequence']}, {'name': 'TUMS', 'type': 'DRUG', 'description': 'Three tablets of TUMS Ultra Strength (US) 1000, taken orally, concomitantly with raltegravir in Period 2, and 12 hours after raltegravir in Period 4', 'armGroupLabels': ['Raltegravir Pre- and 4 Period Sequence']}, {'name': 'Leader Antacid', 'type': 'DRUG', 'description': '20 mL Leader Antacid Maximum Strength (MS) taken orally 12 hours after raltegravir, in Period 3', 'armGroupLabels': ['Raltegravir Pre- and 4 Period Sequence']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}