Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-22 @ 10:25 AM
Study NCT ID:
NCT06578702
Status:
RECRUITING
Last Update Posted:
2024-08-29
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Intermittent Triple Therapies in Real Life
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of HIV viral load', 'timeFrame': '48 weeks after reduction of the HIV viral load'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV Infections', 'Intermittent Triple Therapy'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The strategy of intermittent triple therapy for people living with HIV was validated in France following the randomized clinical trial QUATUOR. There is little data in real life, as shown in the meta-analysis of Parienti JJ et al.\n\nCurrently this strategy is proposed by some teams in France, but is not recommended internationally.\n\nThe research hypothesis is that intermittent treatment is an effective and safe option in a therapeutic lightening strategy in people living with HIV People living with HIV adults followed in Strasbourg who have benefited from intermittent treatment The expected results will consist of an improvement in knowledge on the efficacy and tolerance of this therapeutic strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult subject (≥ 18 years old) living with HIV monitored at the Trait d'Union/Infectious Diseases department in Strasbourg and having benefited from intermittent triple therapy", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Adult subject (≥ 18 years old)\n* Living with HIV monitored at the Trait d'Union/Infectious Diseases department in Strasbourg\n* Having benefited from intermittent triple therapy between 01/01/2017 and 31/01/2024\n\nExclusion criteria:\n\n* Subject (and/or their legal representative if applicable) having expressed their opposition to the reuse of their data for scientific research purposes."}, 'identificationModule': {'nctId': 'NCT06578702', 'acronym': 'ETRIVIE', 'briefTitle': 'Evaluation of Intermittent Triple Therapies in Real Life', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of Intermittent Triple Therapies in Real Life', 'orgStudyIdInfo': {'id': '9238'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Axel URSENBACH, MD', 'role': 'CONTACT', 'email': 'axel.ursenbach@chru-strasbourg.fr', 'phone': '33 3 69 55 13 52'}, {'name': 'Axel URSENBACH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Rey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul Klee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Céline Melouno, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Baptiste Hoellinger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Lemmet, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service Le Trait d'Union - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Axel URSENBACH, MD', 'role': 'CONTACT', 'email': 'axel.ursenbach@chru-strasbourg.fr', 'phone': '33 3 69 55 13 52'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}