Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-03 @ 7:10 PM
Study NCT ID:
NCT01450059
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2011-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Umbilical Cord blood Blood from peripheral vene'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2011-10-11', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal CD4+ t-cells in HiV exposed Newborns', 'timeFrame': 'Six weeks after date of birth', 'description': 'The maternal CD4+ t-cells are measured by microchimersimanalysis'}], 'secondaryOutcomes': [{'measure': 'HiV transmission rate', 'timeFrame': '6 month after birth', 'description': 'Measurement of HiV PCR at the age of 6 month after birth'}, {'measure': 'Analysis of HiV in maternal CD4+ t-cells', 'timeFrame': '2 month after delivery', 'description': 'HiV-PCR analysis from maternal CD4+ cells'}, {'measure': 'Measurement of maternal CD8+ t-cells in the Newborn', 'timeFrame': '6 weeks', 'description': 'Measurement of maternal CD8+ t-cells by microchimerismanalysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human Immunodeficiency Virus', 'Microchimerism', 'Maternal-Fetal Exchange', 'Gestation', 'HiV-vertical transmission'], 'conditions': ['Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '20059573', 'type': 'BACKGROUND', 'citation': 'European Collaborative Study; Boer K, England K, Godfried MH, Thorne C. Mode of delivery in HIV-infected pregnant women and prevention of mother-to-child transmission: changing practices in Western Europe. HIV Med. 2010 Jul 1;11(6):368-78. doi: 10.1111/j.1468-1293.2009.00800.x. Epub 2010 Jan 4.'}, {'pmid': '19172555', 'type': 'BACKGROUND', 'citation': 'Gemeinsame Erklarung* der Deutschen AIDS-Gesellschaft (DAIG); Osterreichischen AIDS-Gesellschaft (OAG); Kompetenznetzes HIV/AIDS sowie des Robert-Koch-Institutes Berlin (RKI); Deutschen Arbeitsgemeinschaft niederniedergelassener Arzte in der Versorgung von HIV-und AIDS-Patienten (DAGNA); Deutschen Gesellschaft fur Kinderheilkunde und Jugendmedizin (DGKJ); Padiatrischen Arbeitsgemeinschaft AIDS Deutschland (PAAD); Deutschen Gesellschaft fur Gynakologie und Geburtshilfe (DGGG); Nationalen Referenzzentrums fur Retroviren (NRZ) der Deutschen AIDS-Hilfe (DAH). [German-Austrian recommendations for HIV treatment during pregnancy and for newborns exposed to HIV--Update 2008]. Dtsch Med Wochenschr. 2009 Jan;134 Suppl 1:S40-54. doi: 10.1055/s-0028-1123974. Epub 2009 Jan 26. No abstract available. German.'}, {'pmid': '17984038', 'type': 'BACKGROUND', 'citation': 'Willasch A, Schneider G, Reincke BS, Shayegi N, Kreyenberg H, Kuci S, Weber G, Van Der Reijden B, Niethammer D, Klingebiel T, Bader P. Sequence polymorphism systems for quantitative real-time polymerase chain reaction to characterize hematopoietic chimerism-high informativity and sensitivity as well as excellent reproducibility and precision of measurement. Lab Hematol. 2007;13(3):73-84.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed Newborns after spontaneous birth in comparison to cesarean section.\n\nThis may have an influence on the risk of vertical HiV transmission.', 'detailedDescription': 'At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis.\n\nAfter 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood.\n\nAdditionally we look for HiV in maternal CD4+ t-cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Minutes', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• HiV exposed Newborns with normal risk of HiV transmission.\n\nExclusion Criteria:\n\n* HiV exposed Newborns wiht elevated or high risk of HiV transmission.\n* HiV exposed Newborns of mothers not full of age.\n* missing informed consent of at least the mother\n* Outborns\n* Asphyxia\n* Major congenital defects\n* Chromosomal anomalies'}, 'identificationModule': {'nctId': 'NCT01450059', 'briefTitle': 'Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section', 'orgStudyIdInfo': {'id': '31082011 FRA Mat Fet Chim'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spontaneous delivery', 'description': 'Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery.'}, {'label': 'Cesarean section', 'description': 'Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Clinic of the Johann Wolfgang-Goethe Univeristy', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Horst Buxmann, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. med. Horst Buxmann', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}