Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05506605
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2022-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592662', 'term': 'doravirine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with confirmed HIV viral load>50 copies/mL', 'timeFrame': 'at week 24', 'description': 'Measured by blood HIV viral load'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with HIV viral load>50 copies/mL', 'timeFrame': 'at week 12 and 48', 'description': 'Measured by blood HIV viral load'}, {'measure': 'Percentage of participants with HIV viral load<50 copies/mL', 'timeFrame': 'at week 12, 24 and 48', 'description': 'Measured by blood HIV viral load'}, {'measure': 'Changes in CD4, CD8 cell counts and ratio CD4/CD8', 'timeFrame': 'at 48 weeks', 'description': 'Measured by blood CD4, CD8 and CD/4/CD8 ratio'}, {'measure': 'Incidence of Treatment-Emergent adverse events and serious adverse events', 'timeFrame': 'at week 48', 'description': 'Measured by numer of AEs and SAEs related to the treatment'}, {'measure': 'AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR', 'timeFrame': 'at weeks 2 and 4'}, {'measure': 'Maximum concentrations (Cmax) of DRV/r and DRV/c with DOR', 'timeFrame': 'at weeks 2 and 4'}, {'measure': 'Concentrations at the end of the dosing interval (C24) of DRV/r and DRV/c with DOR', 'timeFrame': 'at weeks 2 and 4'}, {'measure': 'Elimination half-life (t1/2) of DRV/r and DRV/c with DOR', 'timeFrame': 'at weeks 2 and 4'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Doravirine', 'Etravirine'], 'conditions': ['HIV-1-infection']}, 'descriptionModule': {'briefSummary': 'Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1-infected subjects with age ≥18 years old.\n* Desire of the patient to simplify their ART-regimen.\n* Having plasma HIV-1 RNA \\< 50 copies/mL during at least the previous 24 weeks.\n* Currently receiving an ETR-containing regimen (unchanged during the previous 24 weeks).\n* Documented pooled/historical genotype or GRT in pro-viral DNA must show the presence of 103N and/or 181C and/or 190A and/or 100I and/or 138K/A.\n\nExclusion Criteria:\n\n* Documented pooled/historical genotype or GRT in pro-viral DNA of any DOR-DRM (Mutations V106A, Y188L, and M230L, and combinations of V106A and L234I; V106A and F227L and L234I; and V106A and 190A and F227L).\n* Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods, for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.\n* Active tuberculosis infection.\n* Any clinical condition or therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements.'}, 'identificationModule': {'nctId': 'NCT05506605', 'briefTitle': 'Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'Open-label, Single-arm, Unicenter and Pilot Study of a Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance', 'orgStudyIdInfo': {'id': 'DoRSwitch.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Switch from Etravirine to Doravirine', 'description': 'Switch from etravirine to Doravirine (Pifeltro) 100 mg each day', 'interventionNames': ['Drug: Doravirine 100Mg Tab']}], 'interventions': [{'name': 'Doravirine 100Mg Tab', 'type': 'DRUG', 'description': 'Switch from Etravirine to Doravirine', 'armGroupLabels': ['Switch from Etravirine to Doravirine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Coordinator', 'investigatorFullName': 'Anna Cruceta', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}}