Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT05421806
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients, virologically suppressed/undetectable (<50 copies/mL) at week 48 who have remained on DOR.', 'timeFrame': 'Week 48 after DOR initiation'}, {'measure': 'Proportion of patients with virologic failure (Cohort 1 - treatment naive)', 'timeFrame': 'on or after week 48 after DOR initiation', 'description': 'i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \\< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \\< 50 copies/mL'}, {'measure': 'Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)', 'timeFrame': 'up to 12 months after initiation of DOR', 'description': 'i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \\< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \\< 50 copies/mL'}, {'measure': 'Proportion of patients switched for reasons other than virological failure.', 'timeFrame': 'up to 12 months after initiation of DOR'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)', 'timeFrame': 'on or after week 48 after DOR initiation', 'description': 'i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA \\< 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \\< 200 copies/mL.'}, {'measure': 'Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)', 'timeFrame': 'up to 12 months after initiation of DOR', 'description': 'i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA \\< 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \\< 200 copies/mL.'}, {'measure': 'Estimated proportion of patients with low level viremia (≥50-<200 copies/mL)', 'timeFrame': 'up to 12 months after initiation of DOR'}, {'measure': 'HIV resistance mutations subtypes for all DOR treated patients with virologic failure', 'timeFrame': 'during the 12-month data collection period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV I Infection']}, 'descriptionModule': {'briefSummary': 'Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period.\n\nRetrospective data from 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, is planned to be collected from 6 - 10 European sites.\n\nThe study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-1 infected patients ≥ 18 years who were ART-naïve or virologically suppressed (VL \\< 50 copies for more than 6 months) and have been started/switched to DOR for at least 12 months at time of data collection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are HIV positive male or female\n* are aged ≥18 years\n* were prescribed and received at least one dose of DOR (without initial dose adjustment).\n* have started/been switched to DOR for at least 12 months at time of data collection\n* had a resistance genotype available before starting DOR\n* had no evidence of DOR-associated resistance mutation\n* were on DOR containing ART regimen that also contained 2 fully active nucleos(t)ides and patient had no documented NRTI resistance mutations to the two NRTIs in the combination.\n* Patients who, at the time of initiation, were:\n\n 1. Category 1: HIV treatment naïve OR\n 2. Category 2: Virologically suppressed (HIV-1 RNA \\<50 copies/mL) for at least 6 months with no evidence of prior virological failure with agents of the NNRTI class\n\nPatients in category 1 and 2 above who have NNRTI mutations that do not impact on DOR (K103N, Y181C, and G190A) using the Stanford algorithm (https://hivdb.stanford.edu/hivdb/by-mutations) can be included in this study.\n\nExclusion Criteria:\n\n* Patients who have DOR as part of their fourth line or higher therapy\n* Patients with prior virological failure with agents of the NNRTI class\n* Patients with no documented resistance testing.\n* Patients with no genotype available at DOR initiation\n* Patients enrolled in DOR trials'}, 'identificationModule': {'nctId': 'NCT05421806', 'acronym': 'DrEW', 'briefTitle': 'A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/', 'organization': {'class': 'OTHER', 'fullName': 'NEAT ID Foundation'}, 'officialTitle': 'A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe', 'orgStudyIdInfo': {'id': 'NEAT1010'}, 'secondaryIdInfos': [{'id': 'NEAT 1010', 'type': 'OTHER', 'domain': 'NEAT ID'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment naive'}, {'label': 'Treatment switched', 'description': 'Virologically suppressed (VL \\< 50 copies for more than 6 months)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Universitaire Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'St Louis Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Anton Pozniak', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chelsea and Westminster NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NEAT ID Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}