[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100066733":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":42,"centralContacts":53,"locations":54,"responsibleParty":101,"collaborators":103,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":53,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":53,"enrollmentInfo":119,"targetDuration":53,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":132,"whyStopped":53,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Pregnant participants will receive a single dose of TDF during active labor. These participants will be hospitalized at the delivery facility through Day 3 postpartum.",[13],"Drug: Tenofovir disoproxil fumarate",{"label":15,"type":10,"description":16,"interventionNames":17},"2","Pregnant participants will not receive TDF. Participants will be hospitalized at the delivery facility through Day 7 postpartum. Their infants will receive TDF at birth and on Days 3 and 5 after birth.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"3","Pregnant participants will be hospitalized at the delivery facility through Day 7 postpartum. They will receive TDF during active labor and their infants will receive TDF at birth and on Days 3 and 5 after birth.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"4","Pregnant participants will be hospitalized at the delivery facility through Day 7 postpartum. Mothers will receive TDF during active labor and their infants will receive TDF at birth and daily for 7 days after birth.",[13],[27,34,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Tenofovir disoproxil fumarate","600-mg tablet taken orally once daily",[9,19,23],[33],"TDF",{"type":28,"name":29,"description":35,"armGroupLabels":36,"otherNames":37},"4-mg\u002Fkg oral suspension taken at birth and on Days 3 and 5 after birth",[15,19],[33],{"type":28,"name":29,"description":39,"armGroupLabels":40,"otherNames":41},"6-mg\u002Fkg oral suspension taken at birth and daily for 7 days after birth",[23],[33],[43,47,50],{"name":44,"affiliation":45,"role":46},"Mark Mirochnick, MD","Boston Medical Center","STUDY_CHAIR",{"name":48,"affiliation":49,"role":46},"Taha Taha, MD, PhD","Johns Hopkins University",{"name":51,"affiliation":52,"role":46},"Regis Kreitchmann, MD","Centro Municipal de DST\u002FAIDS, Irmandade Santa Casa de Misericordia de Porto Alegre",null,[55,67,77,82,91],{"facility":56,"status":53,"city":57,"state":58,"zip":53,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":53},"Federal Univ. of Minas Gerais","Belo Horizonte","Minas Gerais","Brazil","BR",{"type":62,"coordinates":63},"Point",[64,65],-43.93778,-19.92083,{"lat":65,"lon":64},{"facility":68,"status":53,"city":69,"state":70,"zip":71,"country":59,"countryCode":60,"cosmosGeoPoint":72,"geoPoint":76,"contacts":53},"Hospital Nossa Senhora da Conceicao CRS","Porto Alegre","Rio Grande do Sul","91350-200",{"type":62,"coordinates":73},[74,75],-51.23019,-30.03283,{"lat":75,"lon":74},{"facility":78,"status":53,"city":69,"state":70,"zip":53,"country":59,"countryCode":60,"cosmosGeoPoint":79,"geoPoint":81,"contacts":53},"Irmandade Santa Casa de Misericórdia de Porto Alegre",{"type":62,"coordinates":80},[74,75],{"lat":75,"lon":74},{"facility":83,"status":53,"city":84,"state":53,"zip":85,"country":59,"countryCode":60,"cosmosGeoPoint":86,"geoPoint":90,"contacts":53},"HSE-Hospital dos Servidores do Estado CRS","Rio de Janeiro","20221-903",{"type":62,"coordinates":87},[88,89],-43.18223,-22.90642,{"lat":89,"lon":88},{"facility":92,"status":53,"city":93,"state":53,"zip":53,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":53},"College of Med. JHU CRS","Blantyre","Malawi","MW",{"type":62,"coordinates":97},[98,99],35.00854,-15.78499,{"lat":99,"lon":98},{"type":102,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[104,106,108],{"name":105,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":107,"class":6},"National Institute on Drug Abuse (NIDA)",{"name":109,"class":6},"National Institute of Mental Health (NIMH)","100066733","phase-1-safety-and-blood-levels-of-tenofovir-disoproxil-fumarate-in-hiv-infected-pregnant-women-and-their-babies-100066733",false,"NCT00120471","Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies","A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and Their Infants","Inclusion Criteria for HIV Infected Pregnant Women:\n\n* HIV-1 infected\n* Intend to deliver at the study site\n* Willing to be contacted or visited at home\n* Willing to be admitted to and remain in the delivery facility through Day 3 postpartum (Cohort 1) or Day 7 postpartum (Cohorts 2 and 3)\n\nExclusion Criteria for HIV Infected Pregnant Women:\n\n* Prior treatment with TDF\n* Active opportunistic infection\n* Serious bacterial infection\n* Chronic malabsorption or diarrhea during the current pregnancy\n* Clinically significant disease or condition that, in the opinion of the study clinician, would interfere with the study\n* Known multiple gestation (twins, etc.) prior to study entry\n* Participation in any other therapeutic or vaccine trial during the current pregnancy\n* Use of certain medications\n* Any other condition or situation that, in the opinion of the investigator, would interfere with the study\n* For Cohort 4, use of atazanavir or lopinavir\u002Fritonavir (Kaletra) within 2 weeks of anticipated delivery\n\nExclusion Criteria for Infants Born to HIV Infected Pregnant Women:\n\n* Birth weight of less than 2 kg (4.4 lbs)\n* Severe congenital malformation or other medical condition that may affect survival and, in the opinion of the clinician, participation in this study\n* Grade 2 or higher serum creatinine level or any other Grade 3 or higher toxicity\n* Part of a multiple birth (twins, etc.)","ALL","18 Years",{"count":120,"type":121},122,"ACTUAL","INTERVENTIONAL",[124],"PHASE1","To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safety, tolerability, and blood levels of TDF in HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi and Brazil.",[127],"HIV Infections",[129,130,131],"Perinatal Transmission","MTCT","HIV Seronegativity","COMPLETED","2021-10-28",{"date":135,"type":121},"2021-11-01",{"date":137,"type":53},"2006-11",{"date":139,"type":121},"2011-12",{"name":5,"class":6},5]