[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100063591":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":25,"locations":38,"responsibleParty":149,"collaborators":151,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":25,"eligibilityCriteria":163,"healthyVolunteers":159,"sex":164,"minAge":165,"maxAge":25,"enrollmentInfo":166,"targetDuration":25,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":177,"whyStopped":25,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"1","ACTIVE_COMPARATOR","Each participant in Cohort 1 received a single 600 mg oral dose of TDF at the start of active labor or 4 hours prior to C-section, with concurrent administration of standard intravenous zidovudine (ZDV) prophylaxis and\u002For other antiretrovirals prescribed by her physician. The infants from Cohort 1 received only the standard 6 weeks of oral ZDV prophylaxis postpartum.",[13,14],"Drug: Emtricitabine\u002FTenofovir disoproxil fumarate","Drug: Tenofovir disoproxil fumarate",{"label":16,"type":10,"description":17,"interventionNames":18},"2","Mothers in Cohort 2 will receive a single dose of 900 mg of TDF combined with 600 mg emtricitabine, along with standard ZDV prophylaxis and\u002For other antiretrovirals prescribed by her physician. Infants will receive a single dose of TDF at 4 mg\u002Fkg combined with 3 mg\u002Fkg emtricitabine as soon as possible after delivery and within 6 hours of age as well as the standard 6 weeks of oral ZDV prophylaxis after birth.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Emtricitabine\u002FTenofovir disoproxil fumarate","900 mg of TDF combined with 600 mg emtricitabine",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Tenofovir disoproxil fumarate","600 mg oral dose of TDF",[9,16],[31,35],{"name":32,"affiliation":33,"role":34},"Patricia M. Flynn, MD","Department of Infectious Disease, St. Jude's Children's Research Hospital","STUDY_CHAIR",{"name":36,"affiliation":37,"role":34},"Arlene D. Bardeguez, MD, MPH, FACOG","Obstetrics, Gynecology, and Women's Health, University of Medicine and Dentistry of New Jersey",[39,52,57,67,77,87,97,106,115,125,134,139],{"facility":40,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Children's National Med. Ctr. Washington DC NICHD CRS","Washington D.C.","District of Columbia","20010","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.03637,38.89511,{"lat":50,"lon":49},{"facility":53,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":54,"geoPoint":56,"contacts":25},"Washington Hosp. Ctr. NICHD CRS",{"type":47,"coordinates":55},[49,50],{"lat":50,"lon":49},{"facility":58,"status":25,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":25},"Univ. of Miami Ped. Perinatal HIV\u002FAIDS CRS","Miami","Florida","33136",{"type":47,"coordinates":63},[64,65],-80.19366,25.77427,{"lat":65,"lon":64},{"facility":68,"status":25,"city":69,"state":70,"zip":71,"country":44,"countryCode":45,"cosmosGeoPoint":72,"geoPoint":76,"contacts":25},"Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program","Chicago","Illinois","60608",{"type":47,"coordinates":73},[74,75],-87.65005,41.85003,{"lat":75,"lon":74},{"facility":78,"status":25,"city":79,"state":80,"zip":81,"country":44,"countryCode":45,"cosmosGeoPoint":82,"geoPoint":86,"contacts":25},"Children's Hospital of Michigan NICHD CRS","Detroit","Michigan","48201",{"type":47,"coordinates":83},[84,85],-83.04575,42.33143,{"lat":85,"lon":84},{"facility":88,"status":25,"city":89,"state":90,"zip":91,"country":44,"countryCode":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":25},"NJ Med. School CRS","Newark","New Jersey","07101-1709",{"type":47,"coordinates":93},[94,95],-74.17237,40.73566,{"lat":95,"lon":94},{"facility":98,"status":25,"city":99,"state":99,"zip":100,"country":44,"countryCode":45,"cosmosGeoPoint":101,"geoPoint":105,"contacts":25},"Nyu Ny Nichd Crs","New York","10016",{"type":47,"coordinates":102},[103,104],-74.00597,40.71427,{"lat":104,"lon":103},{"facility":107,"status":25,"city":108,"state":99,"zip":109,"country":44,"countryCode":45,"cosmosGeoPoint":110,"geoPoint":114,"contacts":25},"Bronx-Lebanon Hosp. IMPAACT CRS","The Bronx","10457",{"type":47,"coordinates":111},[112,113],-73.86641,40.84985,{"lat":113,"lon":112},{"facility":116,"status":25,"city":117,"state":118,"zip":119,"country":44,"countryCode":45,"cosmosGeoPoint":120,"geoPoint":124,"contacts":25},"Hahnemann Univ. Hosp.","Philadelphia","Pennsylvania","19102-1192",{"type":47,"coordinates":121},[122,123],-75.16362,39.95238,{"lat":123,"lon":122},{"facility":126,"status":25,"city":127,"state":128,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":129,"geoPoint":133,"contacts":25},"Regional Med. Ctr. at Memphis","Memphis","Tennessee",{"type":47,"coordinates":130},[131,132],-90.04898,35.14953,{"lat":132,"lon":131},{"facility":135,"status":25,"city":127,"state":128,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":136,"geoPoint":138,"contacts":25},"St. Jude\u002FUTHSC CRS",{"type":47,"coordinates":137},[131,132],{"lat":132,"lon":131},{"facility":140,"status":25,"city":141,"state":25,"zip":25,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":25},"San Juan City Hosp. PR NICHD CRS","San Juan","Puerto Rico","PR",{"type":47,"coordinates":145},[146,147],-66.10572,18.46633,{"lat":147,"lon":146},{"type":150,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[152,154],{"name":153,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":155,"class":156},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK","100063591","phase-1-safety-of-tenofovir-disoproxil-fumarate-tdf-and-emtricitabinetdf-in-hiv-infected-pregnant-women-and-their-infants-100063591",false,"NCT00076791","Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine\u002FTDF in HIV Infected Pregnant Women and Their Infants","A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants","Inclusion Criteria for Mothers:\n\n* HIV infected\n* 34 weeks or more (third trimester) into pregnancy at study screening\n* Have access to a participating AIDS clinical trial unit (ACTU) and are willing to be followed at location for the duration of the study\n\nExclusion Criteria for Mothers:\n\n* Prior treatment with TDF, including coformulated drugs that contain TDF, during current pregnancy\n* Active opportunistic infection and\u002For serious bacterial infection at time of study entry\n* Certain abnormal laboratory values at study screening\n* Chronic malabsorption or chronic diarrhea\n* Certain medical or obstetrical complications during the current pregnancy\n* Fetal abnormalities as measured by ultrasound screening performed at 18 weeks into pregnancy or later\n* Intend to breastfeed\n* Current alcohol abuse or use of illicit substances\n* Participation in any other therapeutic or vaccine perinatal treatment trial during the current pregnancy, unless given permission by the protocol chairs\n* Require certain medications","FEMALE","18 Years",{"count":167,"type":168},66,"ACTUAL","INTERVENTIONAL",[171],"PHASE1","Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine\u002FTDF (FTC\u002FTDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.",[174],"HIV Infections",[176],"HIV Seronegativity","COMPLETED","2021-10-28",{"date":180,"type":168},"2021-11-01",{"date":182,"type":25},"2004-03",{"date":184,"type":168},"2011-03",{"name":5,"class":6},12]