[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100065922":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":31,"locations":51,"responsibleParty":109,"collaborators":111,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":31,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":31,"enrollmentInfo":124,"targetDuration":31,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":141,"whyStopped":31,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: LPV\u002Fr x 7d","EXPERIMENTAL","NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and BID for 7 days postpartum, ddI 250 mg orally daily (if body weight \\\u003C60 kg) or 400 mg orally twice daily (if body weight \\>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV\u002Fr 400\u002F100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.",[13,14,15,16],"Drug: Didanosine, enteric-coated","Drug: Lopinavir\u002Fritonavir","Drug: Nevirapine","Drug: Zidovudine",{"label":18,"type":10,"description":19,"interventionNames":20},"Arm B: no LPV\u002Fr","NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum , ddI 250 mg orally daily (if body weight \\\u003C60 kg) or 400 mg orally daily (if body weight \\>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.",[13,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Arm C: LPV\u002Fr x 30d","NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum , ddI 250 mg orally daily (if body weight \\\u003C60 kg) or 400 mg orally daily (if body weight \\>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum,LPV\u002Fr 400\u002F100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.",[13,14,15,16],[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Didanosine, enteric-coated","once daily",[9,18,22],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Lopinavir\u002Fritonavir","twice daily",[9,22],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Nevirapine","single-dose at the onset of labor",[9,18,22],{"type":27,"name":41,"description":34,"armGroupLabels":42,"otherNames":31},"Zidovudine",[9,18,22],[44,48],{"name":45,"affiliation":46,"role":47},"Russell Van Dyke, MD","Tulane University Medical School","STUDY_CHAIR",{"name":49,"affiliation":50,"role":47},"Gonzague J. Jourdain, MD","Program for HIV Prevention and Treatment \u002F IRD054, Department of Immunology and Infectious Diseases, Harvard School of Public Health",[52,59,69,78,87,91,100],{"facility":53,"status":31,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"Bhumibol Adulyadej Hosp. CRS","Saimai","Bangkok","10220","Thailand","TH",{"facility":60,"status":31,"city":55,"state":61,"zip":62,"country":57,"countryCode":58,"cosmosGeoPoint":63,"geoPoint":68,"contacts":31},"Siriraj Hospital Mahidol University CRS","Bangkoknoi","10700",{"type":64,"coordinates":65},"Point",[66,67],100.50144,13.75398,{"lat":67,"lon":66},{"facility":70,"status":31,"city":71,"state":31,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":31},"Prapokklao Hosp. CRS","Chanthaburi","22000",{"type":64,"coordinates":74},[75,76],102.10447,12.60961,{"lat":76,"lon":75},{"facility":79,"status":31,"city":80,"state":31,"zip":81,"country":57,"countryCode":58,"cosmosGeoPoint":82,"geoPoint":86,"contacts":31},"Chiang Mai University Pediatrics-Obstetrics CRS","Chiang Mai","50200",{"type":64,"coordinates":83},[84,85],98.98468,18.79038,{"lat":85,"lon":84},{"facility":88,"status":31,"city":89,"state":31,"zip":90,"country":57,"countryCode":58,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"Chiangrai Prachanukroh Hospital CRS","Chiangrai","57000",{"facility":92,"status":31,"city":93,"state":31,"zip":94,"country":57,"countryCode":58,"cosmosGeoPoint":95,"geoPoint":99,"contacts":31},"Chonburi Hosp. CRS","Chon Buri","20000",{"type":64,"coordinates":96},[97,98],100.98345,13.3622,{"lat":98,"lon":97},{"facility":101,"status":31,"city":102,"state":31,"zip":103,"country":57,"countryCode":58,"cosmosGeoPoint":104,"geoPoint":108,"contacts":31},"Phayao Provincial Hosp. CRS","Phayao","56000",{"type":64,"coordinates":105},[106,107],99.87883,19.19203,{"lat":107,"lon":106},{"type":110,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[112],{"name":113,"class":6},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100065922","phase-2-reducing-the-incidence-of-nevirapine-resistance-mutations-in-pregnant-hiv-infected-women-who-receive-anti-hiv-drugs-prior-to-and-after-giving-birth-100065922",true,"NCT00109590","Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth","Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of Zidovudine\u002FDidanosine or Zidovudine\u002FDidanosine\u002FLopinavir\u002FRitonavir","Inclusion Criteria for Mothers:\n\n* HIV infected\n* Pregnant with a viable fetus\n* Between 28 and 38 weeks of pregnancy\n* CD4 count greater than 250 cells\u002Fmm3 within 30 days prior to study entry\n* Able to receive oral ART during labor\n* Willing to use acceptable forms of contraception while on study treatment\n* Able to provide written informed consent\n\nExclusion Criteria for Mothers:\n\n* Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV\n* Any ART other than ZDV during a previous pregnancy or the current pregnancy\n* Certain medications\n* Planning to receive additional ART during the first 8 weeks postpartum\n* Planning to breastfeed\n* Unlikely to comply with postpartum study requirements, in the opinion of the investigator\n* Certain abnormal laboratory values within 30 days prior to study entry",false,"FEMALE","18 Years",{"count":125,"type":126},175,"ACTUAL","INTERVENTIONAL",[129],"PHASE2","The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir\u002Fritonavir (LPV\u002Fr) will also be studied.\n\nStudy hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).",[132],"HIV Infections",[134,135,136,137,138,139,140],"HIV Seronegativity","Treatment Naive","Pregnancy","Perinatal Transmission","Vertical Transmission","Mother-To-Child Transmission","MTCT","COMPLETED","2021-11-03",{"date":144,"type":126},"2021-11-05",{"date":146,"type":31},"2006-06",{"date":148,"type":126},"2009-11",{"name":5,"class":6},7]