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JL","STUDY_CHAIR",{"name":17,"affiliation":7,"role":15},"Sperling R",[19,32,41,47,53,62,68,78,87,97,103,113,119,128,138,147],{"facility":20,"status":7,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":7},"UCSD Med Ctr \u002F Pediatrics \u002F Clinical Sciences","La Jolla","California","920930672","United States","US",{"type":27,"coordinates":28},"Point",[29,30],-117.2742,32.84727,{"lat":30,"lon":29},{"facility":33,"status":7,"city":34,"state":22,"zip":35,"country":24,"countryCode":25,"cosmosGeoPoint":36,"geoPoint":40,"contacts":7},"Los Angeles County - USC Med Ctr","Los Angeles","90033",{"type":27,"coordinates":37},[38,39],-118.24368,34.05223,{"lat":39,"lon":38},{"facility":42,"status":7,"city":34,"state":22,"zip":43,"country":24,"countryCode":25,"cosmosGeoPoint":44,"geoPoint":46,"contacts":7},"UCLA Med Ctr \u002F 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School","Worcester","016550001",{"type":27,"coordinates":124},[125,126],-71.80229,42.26259,{"lat":126,"lon":125},{"facility":129,"status":7,"city":130,"state":131,"zip":132,"country":24,"countryCode":25,"cosmosGeoPoint":133,"geoPoint":137,"contacts":7},"Univ of Medicine & Dentistry of New Jersey \u002F Univ Hosp","Newark","New Jersey","071032714",{"type":27,"coordinates":134},[135,136],-74.17237,40.73566,{"lat":136,"lon":135},{"facility":139,"status":7,"city":140,"state":140,"zip":141,"country":24,"countryCode":25,"cosmosGeoPoint":142,"geoPoint":146,"contacts":7},"Mount Sinai Med Ctr \u002F Pediatrics","New York","10029",{"type":27,"coordinates":143},[144,145],-74.00597,40.71427,{"lat":145,"lon":144},{"facility":148,"status":7,"city":149,"state":7,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":7},"San Juan City Hosp","San Juan","009367344","Puerto Rico","PR",{"type":27,"coordinates":154},[155,156],-66.10572,18.46633,{"lat":156,"lon":155},{"type":159,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100053896","phase-1-a-phase-i-study-of-safety-and-pharmacokinetics-of-nevirapine-in-hiv-1-infected-pregnant-women-and-neonates-born-to-hiv-1-infected-mothers-100053896",false,"NCT00000808","A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* AZT (mothers and neonates).\n* Oral asthma inhalers (mothers).\n\nConcurrent Treatment:\n\nAllowed:\n\n* Phototherapy (neonates).\n\nMOTHERS must have:\n\n* HIV infection.\n* Estimated gestational age \\>= 34 weeks.\n* No active opportunistic infection at study entry.\n\nPER AMENDMENT 8\u002F27\u002F96:\n\n* A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies\u002Fml.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nMOTHERS with the following symptoms or conditions are excluded:\n\n* Intrauterine growth retardation.\n* Fetal anomaly incompatible with life as determined by pre-entry ultrasound.\n* Participation during current pregnancy in any other therapeutic or vaccine perinatal trial.\n* Known hypersensitivity to any benzodiazepine.\n* Serious bacterial infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any antiretroviral other than AZT.\n* Corticosteroids (other than oral asthma inhalers).\n* Anticoagulants.\n* Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin).\n* Benzodiazepines other than study drug.\n* Phenobarbital.\n* Barbiturates.\n* Antacids.\n* Magnesium sulfate.\n\nPrior Medication:\n\nExcluded:\n\n* Prior nevirapine.\n\nCurrent use of illicit substances and\u002For active chronic alcohol use.","FEMALE","13 Years","60 Years",{"count":170,"type":7},49,"INTERVENTIONAL",[173],"PHASE1","To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.\n\nTreatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.",[176,177],"HIV Infections","Pregnancy",[177,179,180,181,11],"Pregnancy Complications, Infectious","Acquired Immunodeficiency Syndrome","AIDS-Related Complex","COMPLETED","2021-10-27",{"date":185,"type":186},"2021-11-04","ACTUAL",{"date":188,"type":186},"1998-09",{"name":5,"class":6},16]