Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04334551
Status:
UNKNOWN
Last Update Posted:
2021-01-29
First Post:
2020-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-04', 'releaseDate': '2023-03-28'}], 'estimatedResultsFirstSubmitDate': '2023-03-28'}}, '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': 'C000592662', 'term': 'doravirine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A pilot, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects who maintain virologic control .', 'timeFrame': '24 weeks', 'description': 'Virologic control is defined by measurement of HIV-1 RNA \\< 50 copies/mL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.\n\nThe study will be performed only on two sites', 'detailedDescription': 'The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult (18 Y.O. or more) women and men infected with HIV.\n\n* Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.\n* Virologically controlled (HIV-1 RNA \\< 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.\n* Presence of at least one major NNRTI mutation.\n* No limitation on the number of previous regimens.\n* HCV and HBV-infected patients are allowed\n\nExclusion Criteria:\n\nHigh level of resistance to doravirine according to historical resistance tests.\n\n* Level of resistance to doravirine superior to that of etravirine\n* Opportunistic or serious active infection or disease\n* Active and untreated malignancy.\n* Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures\n* Pregnancy.\n* Active treatment for hepatitis C is forbidden at entry but will be allowed after 3'}, 'identificationModule': {'nctId': 'NCT04334551', 'briefTitle': 'HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance', 'organization': {'class': 'NETWORK', 'fullName': 'Clinique du Quartier Latin'}, 'officialTitle': 'A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of Switches From Etravirine to Doravirine, in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance', 'orgStudyIdInfo': {'id': 'Doravirine and HIV VT#59184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'switch from etravirine to doravirine', 'description': 'switches to doravirine,', 'interventionNames': ['Drug: Doravirine']}], 'interventions': [{'name': 'Doravirine', 'type': 'DRUG', 'description': 'switches from etravirine to doravirine, in experienced HIV patients', 'armGroupLabels': ['switch from etravirine to doravirine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L 4E9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ioannis vertzagias', 'role': 'CONTACT', 'email': 'ivertzagias@cmql.ca', 'phone': '5142853401'}, {'name': 'Benoit Trottier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Du Quartier Latin', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4E9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ioannis vertzagias', 'role': 'CONTACT', 'email': 'ivertzagias@cmql.ca', 'phone': '5142853401'}, {'name': 'Benoit Trottier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Du Quartier Latin', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'CS 90632', 'city': 'Fort-de-France', 'state': 'Fort de France', 'status': 'NOT_YET_RECRUITING', 'country': 'Martinique', 'contacts': [{'name': 'André Cabie', 'role': 'CONTACT', 'email': 'Andre.CABIE@chu-martinique.fr', 'phone': '0596 55 23 73'}, {'name': 'Lise Cuzin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Martinique', 'geoPoint': {'lat': 14.60365, 'lon': -61.07418}}], 'centralContacts': [{'name': 'Ioannis vertzagias', 'role': 'CONTACT', 'email': 'ivertzagias@cmql.ca', 'phone': '5142853401'}, {'name': 'benoit trottier, MD', 'role': 'CONTACT', 'email': 'bentrotte@gmail.com', 'phone': '5142853401'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique du Quartier Latin', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Merck Frosst Canada Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Benoit Trottier Principal Investigator', 'investigatorFullName': 'Benoit Trottier', 'investigatorAffiliation': 'Clinique du Quartier Latin'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-28', 'type': 'RELEASE'}, {'date': '2024-01-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Benoit Trottier, Dr Benoit Trottier Principal Investigator, Clinique du Quartier Latin'}}}}