Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT04024150
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Newborn immunity', 'timeFrame': '18 months', 'description': 'T cells immune repertoire integrity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-integrases treatment', 'Antiretroviral treatment', 'Pregnancy'], 'conditions': ['Anti-integrases']}, 'referencesModule': {'references': [{'pmid': '36343360', 'type': 'BACKGROUND', 'citation': 'de Villartay JP, Pannier E, Sibiude J, Frange P, Tubiana R, Blanche S. Brief Report: T-Cell Receptor alpha Repertoire Diversity at Birth After in utero Exposure to HIV Integrase Strand-Transfer Inhibitors. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):260-262. doi: 10.1097/QAI.0000000000003130.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.', 'detailedDescription': 'Antiretroviral treatment during pregnancy is remarkably effective in preventing the transmission of mother-to-child viruses. Molecules of the class of anti-integrases are still little used during pregnancy, but their prescription is increasing given their intrinsic effectiveness and their overall tolerance profile.\n\nThe integrase of HIV-1, responsible for the integration of viral DNA in cellular DNA, has a functional similarity with human RAG1 / 2 proteins, responsible for V (D) J recombination. RAG1 / 2 proteins alteration is associated in human clinic with immune disturbances of varied severity.\n\nThe objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborns exposed in utero to an antiretroviral therapy and born in the maternities of Paris AP-HP hospitals: Necker, Pitié-Salpétrière, Bichat, Louis Mourier and Cochin (Port-Royal).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No parental opposition after information. "Exposed" group :\n* Newborn at term exposed to raltegravir (RTG) before 8 weeks of gestation and until the end of pregnancy. Children exposed to elvitegravir (ETG), dolutegravir (DTG) or bictegravir (BTG) may be included but will be analyzed separately.\n\n"Control" group :\n\n\\- Term neonate exposed to antiretroviral therapy without anti-integrase.\n\nExclusion Criteria:\n\n* Prematurity less than 36 weeks of gestation.\n* Organ dysfunction.\n* Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.'}, 'identificationModule': {'nctId': 'NCT04024150', 'acronym': 'RAGIIF', 'briefTitle': 'Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of in Utero Exposure to Anti-integrase Antiretrovirals on the Newborn Immune System', 'orgStudyIdInfo': {'id': 'APHP190394'}, 'secondaryIdInfos': [{'id': '2019-A00926-51', 'type': 'OTHER', 'domain': 'ID RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborns exposed', 'description': 'Newborns exposed in-utero to raltegravir', 'interventionNames': ['Biological: Blood test']}, {'label': 'Newborns controls', 'description': 'Newborns exposed to antiretroviral therapy without anti-integrase', 'interventionNames': ['Biological: Blood test']}], 'interventions': [{'name': 'Blood test', 'type': 'BIOLOGICAL', 'description': 'Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup', 'armGroupLabels': ['Newborns controls', 'Newborns exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'AP-HP, Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital de la Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Bichat-Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Stéphane Blanche, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Jean-Pierre de Villartay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}