Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-29 @ 6:59 AM
Study NCT ID:
NCT05536466
Status:
UNKNOWN
Last Update Posted:
2022-09-10
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC of doravirine', 'timeFrame': '24 hours', 'description': 'area under the curve, doravirine'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '24 weeks', 'description': 'adverse events'}, {'measure': 'HIV viral load', 'timeFrame': '24 weeks', 'description': 'HIV viral load'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['doravirine', 'pharmacokinetics'], 'conditions': ['HIV Infections', 'Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-infected\n* VL suppressed \\<40c/ml for at least 6 months, blips are allowed\n* planned to have bariatric surgery (gastric bypass or gastric sleeve)\n* Able to sign informed consent\n* Age \\> or equal to 18 years\n* Using doravirine for at least 4 weeks prior to BS with VL \\< 40 copies/mL prior to the surgery\n\nExclusion Criteria:\n\n* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation\n* Requires or is anticipated to require any of the prohibited medications known to contradict/interact with doravirine\n* Has significant hypersensitivity or other contraindication to doravirine\n* Creatinine clearance \\<40 ml/min\n* Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)\n* Pregnancy or planning to be pregnant during first 6 months postbariatric surgery."}, 'identificationModule': {'nctId': 'NCT05536466', 'acronym': 'LABRADOR', 'briefTitle': 'The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine', 'orgStudyIdInfo': {'id': 'LABRADOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'doravirine treatment', 'description': 'patients stable on doravirine and candidate for bariatric surgery', 'interventionNames': ['Procedure: bariatric surgery']}], 'interventions': [{'name': 'bariatric surgery', 'type': 'PROCEDURE', 'description': 'bariatric surgery', 'armGroupLabels': ['doravirine treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Leena Zino', 'role': 'CONTACT', 'email': 'leena.zino@radboudumc.nl', 'phone': '0031243611111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}