Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT02404805
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C562325', 'term': 'dolutegravir'}, {'id': 'D000069616', 'term': 'Simeprevir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.kiser@ucdenver.edu', 'phone': '(303) 724-6131', 'title': 'Dr. Jennifer Kiser', 'organization': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time of consenting to study exit (Phone follow up 7 days after final intensive PK visit, max 3 months)', 'description': 'AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/.', 'eventGroups': [{'id': 'EG000', 'title': 'Simeprevir Only', 'description': 'Simeprevir tablets 150mg, once daily x 7 days.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dolutegravir Only', 'description': 'Dolutegravir tablets 50mg, once daily x 7 days.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dolutegravir and Simeprevir Co-administered:', 'description': 'Dolutegravir and simeprevir co-administered:\n\ndolutegravir tablets 50mg, once daily, and simeprevir tablets 150mg, once daily, x 7 days', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal issues (stomach pain, gas, vomiting, nausea, diarrhea)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photosensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Labs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Simeprevir AUC Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simeprevir Administered Alone', 'description': 'simeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'OG001', 'title': 'Simeprevir and Dolutegravier Co-administered', 'description': 'Dolutegravir and simeprevir together:\n\ndolutegravir tablets 50mg, once daily and simeprevir tablets 150mg, once daily x 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '30946', 'spread': '80', 'groupId': 'OG000'}, {'value': '30333', 'spread': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7', 'description': 'Determine simeprevir area-under-the concentration time curve (AUC) when administered alone and when being co-administered with Dolutegravier.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only arms that included Simeprevir administration are included.'}, {'type': 'PRIMARY', 'title': 'Dolutegravir AUC Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dolutegravir Administered Alone', 'description': 'dolutegravir: dolutegravir tablets 50mg, once daily x 7 days.'}, {'id': 'OG001', 'title': 'Simeprevir and Dolutegravier Co-administered', 'description': 'Dolutegravir and simeprevir co-administered:\n\ndolutegravir tablets 50mg, once daily and simeprevir tablets 150mg, once daily x 7 da'}], 'classes': [{'categories': [{'measurements': [{'value': '68186', 'spread': '30', 'groupId': 'OG000'}, {'value': '78433', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7', 'description': 'Determine Dolutegravir area-under-the concentration time curve (AUC) when administered alone and when co-administered with simeprevir.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only arms that included Dolutegravir administration are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1a', 'description': 'Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'FG001', 'title': 'Sequence 1b', 'description': 'Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'FG002', 'title': 'Sequence 2a', 'description': 'Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'FG003', 'title': 'Sequence 2b', 'description': 'Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'FG004', 'title': 'Sequence 3a', 'description': 'Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'FG005', 'title': 'Sequence 3b', 'description': 'Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1a', 'description': 'Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'BG001', 'title': 'Sequence 1b', 'description': 'Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'BG002', 'title': 'Sequence 2a', 'description': 'Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'BG003', 'title': 'Sequence 2b', 'description': 'Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'BG004', 'title': 'Sequence 3a', 'description': 'Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'BG005', 'title': 'Sequence 3b', 'description': 'Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.\n\ndolutegravir: dolutegravir tablets 50mg, once daily x 7 days.\n\nsimeprevir: simeprevir tablets 150mg, once daily x 7 days.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '34.3', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '42'}, {'value': '36.4', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '52'}, {'value': '35.6', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '49'}, {'value': '35.7', 'groupId': 'BG004', 'lowerLimit': '26', 'upperLimit': '45'}, {'value': '33.8', 'groupId': 'BG005', 'lowerLimit': '25', 'upperLimit': '44'}, {'value': '34.3', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'ETHNICITY', 'categories': [{'title': 'CAUCASIAN', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}, {'title': 'HISPANIC', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2015-03-18', 'resultsFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-23', 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simeprevir AUC Pharmacokinetics', 'timeFrame': 'Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7', 'description': 'Determine simeprevir area-under-the concentration time curve (AUC) when administered alone and when being co-administered with Dolutegravier.'}, {'measure': 'Dolutegravir AUC Pharmacokinetics', 'timeFrame': 'Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7', 'description': 'Determine Dolutegravir area-under-the concentration time curve (AUC) when administered alone and when co-administered with simeprevir.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dolutegravir', 'simeprevir', 'HIV', 'HCV'], 'conditions': ['HIV', 'Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '29029135', 'type': 'DERIVED', 'citation': 'MacBrayne CE, Castillo-Mancilla J, Burton JR Jr, MaWhinney S, Wagner CB, Micke K, Fey J, Huntley RT, Larson B, Bushman LR, Kiser JJ. Small increase in dolutegravir trough, but equivalent total dolutegravir exposure with simeprevir in HIV/HCV seronegative volunteers. J Antimicrob Chemother. 2018 Jan 1;73(1):156-159. doi: 10.1093/jac/dkx344.'}]}, 'descriptionModule': {'briefSummary': 'The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.', 'detailedDescription': 'To investigate the potential for drug interactions between simeprevir and dolutegravir, participants will receive each drug alone and the drugs in combination for 7 days. The pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ages 18-60 years\n* Absence of HIV-1 and HCV antibodies at screening,\n* Ability and willingness to give written informed consent before the first trial-related activity.\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements\n* Participation in any investigational drug study within 30 days prior to study entry\n* Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results\n* Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives\n* Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry\n* Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis,\n* History of significant drug allergy (i.e., anaphylaxis and/or angioedema)\n* Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS grading table") and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range (ULN)); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above.'}, 'identificationModule': {'nctId': 'NCT02404805', 'briefTitle': 'Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/Hepatitis C Virus (HCV) Seronegative Volunteers', 'orgStudyIdInfo': {'id': '15-0106'}, 'secondaryIdInfos': [{'id': '152252', 'type': 'OTHER_GRANT', 'domain': 'ViiV Healthcare'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1a', 'description': 'Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.', 'interventionNames': ['Drug: dolutegravir', 'Drug: simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 1b', 'description': 'Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.', 'interventionNames': ['Drug: dolutegravir', 'Drug: simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2a', 'description': 'Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.', 'interventionNames': ['Drug: dolutegravir', 'Drug: simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2b', 'description': 'Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.', 'interventionNames': ['Drug: dolutegravir', 'Drug: simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3a', 'description': 'Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.', 'interventionNames': ['Drug: dolutegravir', 'Drug: simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3b', 'description': 'Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.', 'interventionNames': ['Drug: dolutegravir', 'Drug: simeprevir']}], 'interventions': [{'name': 'dolutegravir', 'type': 'DRUG', 'description': 'dolutegravir tablets 50mg, once daily x 7 days.', 'armGroupLabels': ['Sequence 1a', 'Sequence 1b', 'Sequence 2a', 'Sequence 2b', 'Sequence 3a', 'Sequence 3b']}, {'name': 'simeprevir', 'type': 'DRUG', 'description': 'simeprevir tablets 150mg, once daily x 7 days.', 'armGroupLabels': ['Sequence 1a', 'Sequence 1b', 'Sequence 2a', 'Sequence 2b', 'Sequence 3a', 'Sequence 3b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jennifer J Kiser, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}