Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04431518
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2020-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of JULUCA in Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629908', 'term': 'dolutegravir, rilpivirine drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgupta1@iu.edu', 'phone': '3172747926', 'title': 'Samir K. Gupta', 'organization': 'Indiana University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dolutegravir (DTG) Ctau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'OG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1259', 'spread': '447', 'groupId': 'OG000'}, {'value': '1666', 'spread': '415', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma Ctau for dolutegravir at the intensive study visit, which occurred between days 11 and 14', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rilpivirine (RPV) Ctau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'OG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '17', 'groupId': 'OG000'}, {'value': '77', 'spread': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma Ctau for rilpivirine at the intensive study visit, which occurred between days 11 and 14', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety of DTG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'OG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The attributable grade 3 or 4 adverse events associated with use of DTG will be assessed during the study. Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Grade 3 indicates a severe event, and Grade 4 indicates a potentially life-threatening event.', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DTG AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'OG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '78095', 'spread': '28979', 'groupId': 'OG000'}, {'value': '75301', 'spread': '23090', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma AUC for dolutegravir at the intensive study visit, which occurred between days 11 and 14', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DTG Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'OG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6346', 'spread': '2593', 'groupId': 'OG000'}, {'value': '5984', 'spread': '2804', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma Cmax for dolutegravir at the intensive study visit, which occurred between days 11 and 14', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'FG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'BG001', 'title': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days\n\nJULUCA 50Mg-25Mg Tablet: One dose of JULUCA will be taken daily for up to 14 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '60'}, {'value': '57.25', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '60'}, {'value': '57.375', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-17', 'size': 550891, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-21T15:40', 'hasProtocol': True}, {'date': '2022-12-19', 'size': 255327, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-21T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Matched case-control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2020-06-09', 'resultsFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-29', 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dolutegravir (DTG) Ctau', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma Ctau for dolutegravir at the intensive study visit, which occurred between days 11 and 14'}, {'measure': 'Rilpivirine (RPV) Ctau', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma Ctau for rilpivirine at the intensive study visit, which occurred between days 11 and 14'}], 'secondaryOutcomes': [{'measure': 'Safety of DTG', 'timeFrame': '30 days', 'description': 'The attributable grade 3 or 4 adverse events associated with use of DTG will be assessed during the study. Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Grade 3 indicates a severe event, and Grade 4 indicates a potentially life-threatening event.'}, {'measure': 'DTG AUC', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma AUC for dolutegravir at the intensive study visit, which occurred between days 11 and 14'}, {'measure': 'DTG Cmax', 'timeFrame': '0 to 24 hours post-dose on the intensive study visit', 'description': 'Steady-state plasma Cmax for dolutegravir at the intensive study visit, which occurred between days 11 and 14'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'ESRD', 'Hemodialysis', 'Pharmacokinetics'], 'conditions': ['HIV/AIDS', 'ESRD']}, 'descriptionModule': {'briefSummary': 'This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.', 'detailedDescription': 'The pharmacokinetics (PK) of dolutegravir (DTG) and rilpivirine (RPV), the components of JULUCA, in patients with end stage renal disease (ESRD) requiring hemodialysis (HD) have not previously been adequately studied. It is possible that the PK of these drugs are affected by renal failure which may then compromise effectiveness and safety. This trial will rigorously assess the plasma PK and protein-binding of these two drugs in 10 HIV-negative patients requiring hemodialysis with 10 matched persons with normal renal function. All participants will receive JULUCA for up to 14 days and then undergo a 24 hour intensive PK evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Negative HIV antibody testing at screening.\n2. For the ESRD requiring HD study group: ESRD requiring chronic hemodialysis for at least 6 months at an established center (not home dialysis).\n\n NOTE: The approximate date that hemodialysis was initiated should be reported, if known.\n\n For the normal renal function group: Estimated CrCl (using the Cockcroft-Gault equation) at screening ≥75mL/min.\n3. Availability of alternative venous access (not used for dialysis) for the purpose of PK sampling.\n4. The following laboratory values obtained within 30 days prior to study entry (obtained either at screening or done as part of routine clinical care):\n\n * AST (SGOT) and ALT (SGPT) less than or equal to ULN\n * Total bilirubin less than or equal to 1.5 x ULN\n * Hemoglobin greater than or equal to 8.0 mg/dL\n5. A negative serum pregnancy test result at screening for all women of reproductive potential who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation.\n6. Males and females, age 18-65 years.\n7. Ability and willingness of participant or legal guardian/representative to provide written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to either dolutegravir or rilpivirine\n2. Use of peritoneal dialysis.\n3. Serious illnesses, other than ESRD, requiring systemic treatment and/or hospitalization within 30 days prior to the Screening Visit.\n4. Known liver cirrhosis, unstable liver disease (presence of ascites, encephalopathy, coagulopathy, esophageal/gastric varices), Child-Pugh Class A, B, or C, or known biliary abnormalities (except for known Gilbert's syndrome or asymptomatic gallstones).\n5. Hepatitis B surface antigen or hepatitis C antibody with detectable RNA at screening.\n6. Known gastrointestinal disease that may lead to poor absorption of the study drugs.\n7. Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n8. Any of the following gastrointestinal signs or symptoms of Grade ≥ 2 within 7 days prior to the Screening Visit or during study drug administration prior to the Intensive PK Study Visit:\n\n * nausea\n * vomiting\n * diarrhea\n * abdominal pain\n9. Use of any of the following within 30 days of initiating study drug:\n\n * Medications known to appreciably inhibit or induce CYP3A enzymes, P-glycoprotein, or UGT1A1 or UGT1A4 enzymes (e.g., anticonvulsants such as carbamazepine, phenytoin, oxacarbamazepine; antimycobacterials such as rifampin, rifabutin and rifapentine; antifungal agents such as ketoconazole, fluconazole and itraconazole; verapamil, clarithromycin, erythromycin)\n * St. John's Wort, echinacea, grapefruits or grapefruit juice, garlic supplements, ginseng, golden seal, and milk thistle\n * Cancer chemotherapeutic agents\n * Investigational agents\n * Immunomodulators, including systemic steroids greater than or equal to 100 mg/day of prednisone (Note: Topical and inhaled corticosteroids are allowed.)\n * Dofetilide\n * Positive pre-study drug screen. Drugs that will be screened for include amphetamines, barbiturates, cocaine and phencyclidine (PCP). Active injected drug users will be excluded from this study.\n10. Use of proton pump inhibitors within 7 days of initiating study drug (H2 blockers are permitted).\n11. Pregnancy and/or breast-feeding.\n12. Moderate to severe depression, defined as a PHQ-9 ≥ 10 at Screening.\n13. Significant change (i.e., more than a 50% change) in tobacco smoking habit within 6 weeks prior to the Screening Visit. Participants who have recently stopped smoking should have stopped smoking more than 6 weeks prior to the Screening Visit. Participants who have recently started smoking should have started more than 6 weeks prior to the Screening Visit.\n14. QTc interval greater than 500 msec at Screening."}, 'identificationModule': {'nctId': 'NCT04431518', 'briefTitle': 'Pharmacokinetics of JULUCA in Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'The Steady-State Pharmacokinetics (PK) of Dolutegravir/Rilpivirine Fixed Dose Combination (FDC) in Patients With End Stage Renal Disease (ESRD) Requiring Hemodialysis (HD)', 'orgStudyIdInfo': {'id': 'ViiV Healthcare IIS 1837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hemodialysis Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days', 'interventionNames': ['Drug: JULUCA 50Mg-25Mg Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Renal Function Group', 'description': 'Receipt of JULUCA one pill per day up to 14 days', 'interventionNames': ['Drug: JULUCA 50Mg-25Mg Tablet']}], 'interventions': [{'name': 'JULUCA 50Mg-25Mg Tablet', 'type': 'DRUG', 'description': 'One dose of JULUCA will be taken daily for up to 14 days', 'armGroupLabels': ['Hemodialysis Group', 'Normal Renal Function Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Samir Gupta', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Samir K Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'IPD will become available after publication of the data, anticipated to be by July 2022.', 'ipdSharing': 'YES', 'description': 'All IPD will provided upon request and approval by the investigators or through online data repositories such as Figshare.', 'accessCriteria': 'Fully available when posted to online repositories. Additional data upon request and approval by the study investigators. The financial sponsor will not have a role in this process.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Samir K. Gupta, MD', 'investigatorAffiliation': 'Indiana University'}}}}