Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02556268
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interaction With HIV Antiretroviral Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}, {'id': 'D000068257', 'term': 'Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068678', 'term': 'Emtricitabine, Rilpivirine, Tenofovir Drug Combination'}, {'id': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'C000631408', 'term': 'abacavir, dolutegravir, and lamivudine drug combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000068696', 'term': 'Rilpivirine'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-05', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC of riociguat', 'timeFrame': 'at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose'}, {'measure': 'Cmax of riociguat', 'timeFrame': 'at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose'}, {'measure': 'AUC of riociguat main metabolite M1 (BAY 60-4552)', 'timeFrame': 'at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose'}, {'measure': 'Cmax of riociguat main metabolite M1 (BAY 60-4552)', 'timeFrame': 'at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single-Dose, Open-Label, Non-Blinded, Non-Placebo-', 'Controlled, Stratified Design'], 'conditions': ['HIV-DDI']}, 'descriptionModule': {'briefSummary': 'To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.\n\n• To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged \\>=18 to \\<65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat\n* No clinical evidence of pulmonary hypertension\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal\n* History of coronary artery disease\n* Symptomatic postural hypotension (e.g. dizziness, lightheadedness)\n* History of bronchial asthma or any other airway disease\n* Renal impairment with creatinine clearance \\<15 mL/min\n* Severe hepatic impairment (Child-Pugh class C)\n* Systolic blood pressure below 100 mmHg'}, 'identificationModule': {'nctId': 'NCT02556268', 'briefTitle': 'Interaction With HIV Antiretroviral Agents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients', 'orgStudyIdInfo': {'id': '17957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Riociguat and ATRIPLA', 'interventionNames': ['Drug: Riociguat (Adempas, BAY 63-2521)', 'Drug: ATRIPLA']}, {'type': 'EXPERIMENTAL', 'label': 'Riociguat and COMPLERA', 'interventionNames': ['Drug: Riociguat (Adempas, BAY 63-2521)', 'Drug: COMPLERA']}, {'type': 'EXPERIMENTAL', 'label': 'Riociguat and STRIBILD', 'interventionNames': ['Drug: Riociguat (Adempas, BAY 63-2521)', 'Drug: STRIBILD']}, {'type': 'EXPERIMENTAL', 'label': 'Riociguat and TRIUMEQ', 'interventionNames': ['Drug: Riociguat (Adempas, BAY 63-2521)', 'Drug: TRIUMEQ']}, {'type': 'EXPERIMENTAL', 'label': 'Riociguat and antiretroviral protease inhibitor with TRIUMEQ', 'interventionNames': ['Drug: Riociguat (Adempas, BAY 63-2521)', 'Drug: Antiretroviral protease inhibitor']}], 'interventions': [{'name': 'Riociguat (Adempas, BAY 63-2521)', 'type': 'DRUG', 'description': '0.5 mg, Oral (fasted conditions), 1 single dose', 'armGroupLabels': ['Riociguat and ATRIPLA', 'Riociguat and COMPLERA', 'Riociguat and STRIBILD', 'Riociguat and TRIUMEQ', 'Riociguat and antiretroviral protease inhibitor with TRIUMEQ']}, {'name': 'ATRIPLA', 'type': 'DRUG', 'description': '600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily', 'armGroupLabels': ['Riociguat and ATRIPLA']}, {'name': 'COMPLERA', 'type': 'DRUG', 'description': '200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily', 'armGroupLabels': ['Riociguat and COMPLERA']}, {'name': 'STRIBILD', 'type': 'DRUG', 'description': '150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily', 'armGroupLabels': ['Riociguat and STRIBILD']}, {'name': 'TRIUMEQ', 'type': 'DRUG', 'description': '600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily', 'armGroupLabels': ['Riociguat and TRIUMEQ']}, {'name': 'Antiretroviral protease inhibitor', 'type': 'DRUG', 'description': 'Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents', 'armGroupLabels': ['Riociguat and antiretroviral protease inhibitor with TRIUMEQ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}