[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053952":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":14,"centralContacts":7,"locations":20,"responsibleParty":148,"collaborators":150,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":7,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":7,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":180,"whyStopped":7,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":7,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,[9,12],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Abacavir sulfate",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Zidovudine",[15,18],{"name":16,"affiliation":7,"role":17},"George Johnson","STUDY_CHAIR",{"name":19,"affiliation":7,"role":17},"Andrew Wiznia",[21,34,44,50,58,68,78,88,98,108,117,127,137],{"facility":22,"status":7,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"UAB, Dept. of Ped., Div. of Infectious Diseases","Birmingham","Alabama","35233","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-86.80249,33.52066,{"lat":32,"lon":31},{"facility":35,"status":7,"city":36,"state":37,"zip":38,"country":26,"countryCode":27,"cosmosGeoPoint":39,"geoPoint":43,"contacts":7},"Usc La Nichd Crs","Los Angeles","California","90033",{"type":29,"coordinates":40},[41,42],-118.24368,34.05223,{"lat":42,"lon":41},{"facility":45,"status":7,"city":36,"state":37,"zip":46,"country":26,"countryCode":27,"cosmosGeoPoint":47,"geoPoint":49,"contacts":7},"UCLA-Los Angeles\u002FBrazil AIDS Consortium (LABAC) CRS","900951752",{"type":29,"coordinates":48},[41,42],{"lat":42,"lon":41},{"facility":51,"status":7,"city":52,"state":37,"zip":7,"country":26,"countryCode":27,"cosmosGeoPoint":53,"geoPoint":57,"contacts":7},"UCSD Maternal, Child, and Adolescent HIV CRS","San Diego",{"type":29,"coordinates":54},[55,56],-117.16472,32.71571,{"lat":56,"lon":55},{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":26,"countryCode":27,"cosmosGeoPoint":63,"geoPoint":67,"contacts":7},"Univ. of Florida Jacksonville NICHD CRS","Jacksonville","Florida","32209",{"type":29,"coordinates":64},[65,66],-81.65565,30.33218,{"lat":66,"lon":65},{"facility":69,"status":7,"city":70,"state":71,"zip":72,"country":26,"countryCode":27,"cosmosGeoPoint":73,"geoPoint":77,"contacts":7},"Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases","Atlanta","Georgia","30306",{"type":29,"coordinates":74},[75,76],-84.38798,33.749,{"lat":76,"lon":75},{"facility":79,"status":7,"city":80,"state":81,"zip":82,"country":26,"countryCode":27,"cosmosGeoPoint":83,"geoPoint":87,"contacts":7},"Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.","Chicago","Illinois","60612",{"type":29,"coordinates":84},[85,86],-87.65005,41.85003,{"lat":86,"lon":85},{"facility":89,"status":7,"city":90,"state":91,"zip":92,"country":26,"countryCode":27,"cosmosGeoPoint":93,"geoPoint":97,"contacts":7},"HMS - Children's Hosp. Boston, Div. of Infectious Diseases","Boston","Massachusetts","021155724",{"type":29,"coordinates":94},[95,96],-71.05977,42.35843,{"lat":96,"lon":95},{"facility":99,"status":7,"city":100,"state":101,"zip":102,"country":26,"countryCode":27,"cosmosGeoPoint":103,"geoPoint":107,"contacts":7},"SUNY Upstate Med. Univ., Dept. of Peds.","Syracuse","New York","13210",{"type":29,"coordinates":104},[105,106],-76.14742,43.04812,{"lat":106,"lon":105},{"facility":109,"status":7,"city":110,"state":101,"zip":111,"country":26,"countryCode":27,"cosmosGeoPoint":112,"geoPoint":116,"contacts":7},"Bronx-Lebanon Hosp. IMPAACT CRS","The Bronx","10457",{"type":29,"coordinates":113},[114,115],-73.86641,40.84985,{"lat":115,"lon":114},{"facility":118,"status":7,"city":119,"state":120,"zip":121,"country":26,"countryCode":27,"cosmosGeoPoint":122,"geoPoint":126,"contacts":7},"DUMC Ped. CRS","Durham","North Carolina","277103499",{"type":29,"coordinates":123},[124,125],-78.89862,35.99403,{"lat":125,"lon":124},{"facility":128,"status":7,"city":129,"state":130,"zip":131,"country":26,"countryCode":27,"cosmosGeoPoint":132,"geoPoint":136,"contacts":7},"Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases","Charleston","South Carolina","294253312",{"type":29,"coordinates":133},[134,135],-79.93275,32.77632,{"lat":135,"lon":134},{"facility":138,"status":7,"city":139,"state":7,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":7},"San Juan City Hosp. PR NICHD CRS","San Juan","009367344","Puerto Rico","PR",{"type":29,"coordinates":144},[145,146],-66.10572,18.46633,{"lat":146,"lon":145},{"type":149,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[151],{"name":152,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100053952","phase-1-a-study-to-test-the-safety-tolerance-and-metabolism-of-abacavir-1592u89-abc-with-standard-zidovudine-zdv-therapy-in-newborn-infants-born-to-hiv-1-infected-women-100053952",false,"NCT00000864","A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women","Phase I Study of Safety, Tolerance, and Pharmacokinetics of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy In Neonates Born to HIV-1 Infected Women","Inclusion Criteria\n\nInfants may be eligible for this study if they:\n\n* Are between birth and 48 hours of age, between 3 and 7 days of age, or between 21 and 28 days of age.\n* Have no serious infections requiring treatment during the study period.\n* Are receiving ZDV therapy.\n* Can tolerate oral feeding.\n* Are born to HIV-positive mothers whose pregnancy lasted at least 37 weeks.\n\nExclusion Criteria\n\nInfants will not be eligible for this study if they:\n\n* Have a major congenital abnormality.\n* Have a serious laboratory or clinical toxicity at time of study entry.\n* Previously enrolled in Part 1 of this study.\n* Are unable to be followed for the duration of this study.","ALL","1 Day","28 Days",{"count":164,"type":7},60,"INTERVENTIONAL",[167],"PHASE1","The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies.\n\nEarly aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.",[170],"HIV Infections",[172,173,174,175,13,176,177,178,179],"Pregnancy","Pregnancy Complications, Infectious","HIV-1","Drug Therapy, Combination","Drug Administration Schedule","Disease Transmission, Vertical","Reverse Transcriptase Inhibitors","Anti-HIV Agents","COMPLETED","2021-10-27",{"date":183,"type":184},"2021-10-28","ACTUAL",{"date":186,"type":184},"2001-01",{"name":5,"class":6},13]