Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT06289361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort IMEA 070 -Lenacapavir Compassional
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection', 'timeFrame': 'Week 26'}], 'secondaryOutcomes': [{'measure': 'incidence of side effects and laboratory abnormalities on LEN treatment', 'timeFrame': 'between week 26 and Week 52'}, {'measure': 'evolution of HIV-1 or HIV-2 RNA over time', 'timeFrame': 'between week 26 and Week 52'}, {'measure': 'evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time', 'timeFrame': 'between week 26 and Week 52'}, {'measure': 'Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)', 'timeFrame': 'between Week 26 and Week 52'}, {'measure': 'Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection', 'timeFrame': 'Week 26'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lenacapavir under compassionate access', 'France', 'Cohort'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023', 'detailedDescription': 'Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients already followed and identified in the centers and having received lenacapavir in compassionate access between January 01st, 2021 and December 20th, 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202\n\nExclusion Criteria:\n\n* Absence of visits with virological assessment subsequent to inclusion visit\n* Participant opposition to use of follow-up data'}, 'identificationModule': {'nctId': 'NCT06289361', 'briefTitle': 'Cohort IMEA 070 -Lenacapavir Compassional', 'organization': {'class': 'OTHER', 'fullName': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba"}, 'officialTitle': 'Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023', 'orgStudyIdInfo': {'id': 'IMEA 070'}}, 'contactsLocationsModule': {'locations': [{'zip': '64100', 'city': 'Bayonne', 'state': 'France', 'country': 'France', 'facility': 'Centre Hospitalier de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '92140', 'city': 'Clamart', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '17000', 'city': 'La Rochelle', 'state': 'France', 'country': 'France', 'facility': 'Hôpital de la Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '92000', 'city': 'Nanterre', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Max Fourestier', 'geoPoint': {'lat': 48.89198, 'lon': 2.20675}}, {'zip': '45100', 'city': 'Orléans', 'state': 'France', 'country': 'France', 'facility': 'CHU La Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '97400', 'city': 'Saint-Denis', 'state': 'LA Reunion', 'country': 'France', 'facility': 'Hôpital Félix Guyon', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97261', 'city': 'Fort-de-France', 'state': 'Martinique', 'country': 'France', 'facility': 'Hopital Zobda Quitman'}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Saint-Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'C.H.D de Vendee', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'André Mignot Hospital', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Centre Hospitalier Bretagne Sud - Hôpital du Scorff', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Bichat Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Delafontaine', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba", 'class': 'OTHER'}, 'collaborators': [{'name': 'Saint-Louis Hospital, Paris, France', 'class': 'OTHER'}, {'name': 'Bichat Hospital', 'class': 'OTHER'}, {'name': 'Saint Antoine University Hospital', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}