Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 10:19 PM
Study NCT ID:
NCT05140603
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.', 'timeFrame': 'Up to 96 weeks.', 'description': 'FDA snapshot algorithm (ITT-exposed).'}], 'secondaryOutcomes': [{'measure': 'Rate of changes in renal biomarkers.', 'timeFrame': 'Up to 48 weeks.', 'description': 'Changes in renal biomarkers from baseline (mean absolute changes in glomerular filtrate estimation (eGFR and CKD-epi equation)/24 (interim analysis) and 48 weeks.'}, {'measure': 'Rate of changes in hepatic parameters.', 'timeFrame': 'Up to 48 weeks.', 'description': 'Changes in hepatic parameters from baseline (median percentage of change in ASL, AST, GGT, AF and bilirubin).'}, {'measure': 'Rate of changes in lipid parameters.', 'timeFrame': 'Up to 48 weeks', 'description': 'Changes in lipid parameters from baseline (median percentage of change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CT-HDL ratio.'}, {'measure': 'Tolerability rate of study patients.', 'timeFrame': 'Up to 48 weeks.', 'description': 'Number of interactions, adverse events and toxicities.'}, {'measure': 'Death rates among trial patients.', 'timeFrame': 'Up to 48 weeks.', 'description': 'Number of patients who died during or after the trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiv']}, 'descriptionModule': {'briefSummary': 'Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.', 'detailedDescription': 'Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.\n\nAll patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021).\n\nMinor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were switched to a doravirine-based regimen from the date of its availability in our center (September 2020) due to clinical considerations and have records available will be retrospectively included until the study approval date (expected July 2021).\n\nMinor resistances in a baseline genotype to NNRTI or prior failure to NNRTI such as nevirapine or efavirenz will be accepted if doravirine is combined with a fully active high genetic barrier drug.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years HIV-1 infected subjects.\n* Switched to a doravirine-based ART regimen under clinician criteria.\n\nExclusion Criteria:\n\n* Doravirine major resistance mutations (accessory mutations are allowed).\n* Major mutations to any of the other drugs combined with doravirine.\n* Pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.'}, 'identificationModule': {'nctId': 'NCT05140603', 'briefTitle': 'Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Ambispective Cohort Study to Evaluate the Effectiveness, Safety and Tolerance of a Doravirine-based Antirretroviral Regimen as a Switching Strategy in Virologically Supressed HIV Infected Patients: Real-world Data', 'orgStudyIdInfo': {'id': 'FIS-DOR-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients who received a doravirine-based regimen.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'contacts': [{'name': 'Nuria Espinosa Aguilera', 'role': 'CONTACT', 'email': 'nuriai.espinosa.sspa@juntadeandalucia.es', 'phone': '955 01 30 98'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Nuria Espinosa Aguilera', 'role': 'CONTACT', 'email': 'nuriai.espinosa.sspa@juntadeandalucia.es', 'phone': '955 01 30 98'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'overallOfficials': [{'name': 'Nuria Espinosa Aguilera', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virgen del Rocío University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}