[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100098265":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":30,"responsibleParty":44,"collaborators":46,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":20,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery",[13],"Drug: Tenofovir 1% vaginal gel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tenofovir 1% vaginal gel","topical gel containing 1% tenofovir",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Richard Beigi, MD, MSc, FACOG","Magee-Women's Hospital of UPMC, Department of Obstetrics\u002FGynecology","STUDY_CHAIR",{"name":27,"affiliation":28,"role":29},"Sharon Hillier, PhD","Microbicides Trial Network","PRINCIPAL_INVESTIGATOR",[31],{"facility":32,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":20},"Pitt CRS","Pittsburgh","Pennsylvania","15213","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-79.99589,40.44062,{"lat":42,"lon":41},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[47,50],{"name":48,"class":49},"Microbicide Trials Network","NETWORK",{"name":51,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100098265","phase-1-blood-levels-of-tenofovir-gel-in-hiv-uninfected-pregnant-women-planning-cesarean-delivery-100098265",false,"NCT00540605","Blood Levels of Tenofovir Gel in HIV Uninfected Pregnant Women Planning Cesarean Delivery","Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas","Inclusion Criteria:\n\n* General good health\n* HIV uninfected\n* Hepatitis B surface antigen negative at screening and enrollment\n* Viable, single pregnancy delivered by cesarean section planned between 37 0\u002F7 to 41 6\u002F7 weeks of pregnancy\n* Normal Pap smear in the 12 months prior to study entry\n* Willing to abstain from vaginal, anal, and receptive oral sex for at least 2 weeks after gel administration\n* Willing to abstain from intravaginal products and practices (including douching) during study participation\n\nExclusion Criteria:\n\n* Maternal or fetal condition that requires urgent cesarean section\n* Documented rupture of the amniotic membranes\n* Known disease in the mother that has a predictable negative effect on placental function\n* Known placental\u002Ffetal abnormalities that could affect placental transfer. More information on this criterion can be found in the protocol.\n* Previously demonstrated hypersensitivity to any components of tenofovir 1% gel\n* Certain abnormal laboratory values\n* Use of vaginal medications within 48 hours of study entry\n* Untreated sexually transmitted infection (STI) or exposure to partner's STI, including chlamydia, gonorrhea, trichomoniasis, and nongonococcal urethritis\n* Symptomatic vaginitis, including bacterial vaginosis and vulvovaginal candidiasis. Participants with asymptomatic signs of bacterial vaginosis and\u002For yeast not excluded.\n* Participation in any other investigational drug or device trial within 30 days of study entry\n* Any social or medical condition that, in the opinion of the investigator, would interfere with the study",true,"FEMALE","18 Years","45 Years",{"count":64,"type":65},21,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","A new approach to HIV prevention currently being studied includes the use of topical microbicides, substances that kill microbes. The purpose of this study is to determine the levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are expecting to deliver by cesarean.",[71],"HIV Infections",[73,74,75],"Microbicide","Pregnancy","HIV Seronegativity","COMPLETED","2021-10-15",{"date":79,"type":65},"2021-10-25",{"date":81,"type":65},"2010-01",{"name":5,"class":6},1]