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USC Med Ctr","Los Angeles","California","90033","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-118.24368,34.05223,{"lat":34,"lon":33},{"facility":37,"status":7,"city":38,"state":39,"zip":40,"country":28,"countryCode":29,"cosmosGeoPoint":41,"geoPoint":45,"contacts":7},"George Washington Univ Med Ctr","Washington D.C.","District of Columbia","20037",{"type":31,"coordinates":42},[43,44],-77.03637,38.89511,{"lat":44,"lon":43},{"facility":47,"status":7,"city":48,"state":49,"zip":50,"country":28,"countryCode":29,"cosmosGeoPoint":51,"geoPoint":55,"contacts":7},"Univ of Miami School of Medicine","Miami","Florida","331361013",{"type":31,"coordinates":52},[53,54],-80.19366,25.77427,{"lat":54,"lon":53},{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":28,"countryCode":29,"cosmosGeoPoint":61,"geoPoint":65,"contacts":7},"Northwestern Univ Med School","Chicago","Illinois","60611",{"type":31,"coordinates":62},[63,64],-87.65005,41.85003,{"lat":64,"lon":63},{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":28,"countryCode":29,"cosmosGeoPoint":71,"geoPoint":75,"contacts":7},"Charity Hosp \u002F Tulane Univ Med School","New Orleans","Louisiana","70112",{"type":31,"coordinates":72},[73,74],-90.07507,29.95465,{"lat":74,"lon":73},{"facility":77,"status":7,"city":68,"state":69,"zip":70,"country":28,"countryCode":29,"cosmosGeoPoint":78,"geoPoint":80,"contacts":7},"Louisiana State Univ Med Ctr \u002F Tulane Med School",{"type":31,"coordinates":79},[73,74],{"lat":74,"lon":73},{"facility":82,"status":7,"city":68,"state":69,"zip":70,"country":28,"countryCode":29,"cosmosGeoPoint":83,"geoPoint":85,"contacts":7},"Tulane Univ School of Medicine",{"type":31,"coordinates":84},[73,74],{"lat":74,"lon":73},{"facility":87,"status":7,"city":88,"state":89,"zip":90,"country":28,"countryCode":29,"cosmosGeoPoint":91,"geoPoint":95,"contacts":7},"Univ of Massachusetts Med Ctr","Worcester","Massachusetts","01655",{"type":31,"coordinates":92},[93,94],-71.80229,42.26259,{"lat":94,"lon":93},{"facility":97,"status":7,"city":98,"state":99,"zip":100,"country":28,"countryCode":29,"cosmosGeoPoint":101,"geoPoint":105,"contacts":7},"SUNY \u002F Erie County Med Ctr at Buffalo","Buffalo","New York","14215",{"type":31,"coordinates":102},[103,104],-78.87837,42.88645,{"lat":104,"lon":103},{"facility":107,"status":7,"city":108,"state":99,"zip":109,"country":28,"countryCode":29,"cosmosGeoPoint":110,"geoPoint":114,"contacts":7},"City Hosp Ctr at Elmhurst \u002F Mount Sinai Hosp","Elmhurst","11373",{"type":31,"coordinates":111},[112,113],-73.87791,40.73649,{"lat":113,"lon":112},{"facility":116,"status":7,"city":99,"state":99,"zip":117,"country":28,"countryCode":29,"cosmosGeoPoint":118,"geoPoint":122,"contacts":7},"Beth Israel Med Ctr \u002F Peter Krueger Clinic","10003",{"type":31,"coordinates":119},[120,121],-74.00597,40.71427,{"lat":121,"lon":120},{"facility":124,"status":7,"city":99,"state":99,"zip":125,"country":28,"countryCode":29,"cosmosGeoPoint":126,"geoPoint":128,"contacts":7},"Mount Sinai Med Ctr","10029",{"type":31,"coordinates":127},[120,121],{"lat":121,"lon":120},{"facility":130,"status":7,"city":131,"state":99,"zip":132,"country":28,"countryCode":29,"cosmosGeoPoint":133,"geoPoint":137,"contacts":7},"Univ of Rochester Medical Center","Rochester","14642",{"type":31,"coordinates":134},[135,136],-77.61556,43.15478,{"lat":136,"lon":135},{"facility":139,"status":7,"city":140,"state":99,"zip":141,"country":28,"countryCode":29,"cosmosGeoPoint":142,"geoPoint":146,"contacts":7},"SUNY - Stony Brook","Stony Brook","117948153",{"type":31,"coordinates":143},[144,145],-73.14094,40.92565,{"lat":145,"lon":144},{"facility":148,"status":7,"city":149,"state":99,"zip":150,"country":28,"countryCode":29,"cosmosGeoPoint":151,"geoPoint":155,"contacts":7},"SUNY \u002F State Univ of New York","Syracuse","13210",{"type":31,"coordinates":152},[153,154],-76.14742,43.04812,{"lat":154,"lon":153},{"facility":157,"status":7,"city":158,"state":99,"zip":159,"country":28,"countryCode":29,"cosmosGeoPoint":160,"geoPoint":164,"contacts":7},"Bronx Municipal Hosp Ctr\u002FJacobi Med Ctr","The Bronx","10461",{"type":31,"coordinates":161},[162,163],-73.86641,40.84985,{"lat":163,"lon":162},{"facility":166,"status":7,"city":158,"state":99,"zip":167,"country":28,"countryCode":29,"cosmosGeoPoint":168,"geoPoint":170,"contacts":7},"Jack Weiler Hosp \u002F Bronx Municipal Hosp","10465",{"type":31,"coordinates":169},[162,163],{"lat":163,"lon":162},{"facility":172,"status":7,"city":158,"state":99,"zip":173,"country":28,"countryCode":29,"cosmosGeoPoint":174,"geoPoint":176,"contacts":7},"Montefiore Med Ctr \u002F Bronx Municipal Hosp","10467",{"type":31,"coordinates":175},[162,163],{"lat":163,"lon":162},{"facility":178,"status":7,"city":179,"state":180,"zip":181,"country":28,"countryCode":29,"cosmosGeoPoint":182,"geoPoint":186,"contacts":7},"Holmes Hosp \u002F Univ of Cincinnati Med Ctr","Cincinnati","Ohio","452670405",{"type":31,"coordinates":183},[184,185],-84.51439,39.12711,{"lat":185,"lon":184},{"facility":188,"status":7,"city":189,"state":180,"zip":190,"country":28,"countryCode":29,"cosmosGeoPoint":191,"geoPoint":195,"contacts":7},"Univ Hosp of Cleveland \u002F Case Western Reserve Univ","Cleveland","44106",{"type":31,"coordinates":192},[193,194],-81.69541,41.4995,{"lat":194,"lon":193},{"facility":197,"status":7,"city":198,"state":199,"zip":200,"country":28,"countryCode":29,"cosmosGeoPoint":201,"geoPoint":205,"contacts":7},"Milton S Hershey Med Ctr","Hershey","Pennsylvania","170330850",{"type":31,"coordinates":202},[203,204],-76.65025,40.28592,{"lat":204,"lon":203},{"facility":207,"status":7,"city":208,"state":199,"zip":209,"country":28,"countryCode":29,"cosmosGeoPoint":210,"geoPoint":214,"contacts":7},"Thomas Jefferson Med College","Philadelphia","19107",{"type":31,"coordinates":211},[212,213],-75.16362,39.95238,{"lat":213,"lon":212},{"facility":216,"status":7,"city":217,"state":218,"zip":219,"country":28,"countryCode":29,"cosmosGeoPoint":220,"geoPoint":224,"contacts":7},"Julio Arroyo","West Columbia","South Carolina","29169",{"type":31,"coordinates":221},[222,223],-81.07398,33.99349,{"lat":223,"lon":222},{"type":226,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100054100","phase-3-comparison-of-trimetrexate-plus-leucovorin-calcium-rescue-versus-sulfamethoxazole-trimethoprim-in-the-treatment-of-pneumocystis-carinii-pneumonia-pcp-in-patients-with-aids-100054100",false,"NCT00001013","Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS","A Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) With Leucovorin Calcium Rescue Versus Trimethoprim \u002F Sulfamethoxazole for Moderately Severe Pneumocystis Carinii Pneumonia in Patients With AIDS","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Acetaminophen:\n* 650 mg prescribed as necessary for temperature \\> 38.7 degrees C. Acetaminophen should not be prescribed as a standing order for more than 48 hours.\n\nPrior Medication:\n\nAllowed:\n\n* Zidovudine (AZT) as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed and the patient's white blood cell count is acceptable.\n* Other myelosuppressive therapies which may be handled in the same manner as AZT.\n* Prophylaxis for Pneumocystis carinii pneumonia (PCP).\n* Unequivocal diagnosis of Pneumocystis carinii pneumonia (PCP) by morphologic confirmation of three or more typical P. carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 6 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 \\\u003C 30 torr on room air. Patient, parent, guardian, or person with power of attorney gives informed consent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients will be excluded for the following reasons:\n\n* History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reaction secondary to antibiotics containing sulfa, trimethoprim, or trimetrexate.\n* History of life-threatening pentamidine toxicity.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia (PCP).\n* Disalcid.\n* Aspirin.\n* Acetaminophen q4h as a standing order for more than 48 hours.\n\nPrior Medication:\n\nExcluded within 14 days of study entry:\n\n* Systemic steroids exceeding physiological replacement.\n* Other investigational drugs including ganciclovir.\n* Excluded within 6 weeks of study entry:\n* Another antiprotozoal regimen for this episode for therapy of active Pneumocystis carinii pneumonia (PCP).\n* Patients who are unable to have arterial blood gas analysis (ABG's) on room air.\n* Patients for whom a liter of intravenous fluid (5 percent dextrose in water) per 24 hours, which is required to maintain blinding, would be medically inadvisable.","ALL","12 Years",{"count":237,"type":7},364,"INTERVENTIONAL",[240],"PHASE3","To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection.",[243,244],"Pneumonia, Pneumocystis Carinii","HIV Infections",[246,247,248,249,250,251,252,253,254,255,256,257,258,15],"Trimethoprim-Sulfamethoxazole Combination","Trimetrexate","AIDS-Related Opportunistic Infections","Pneumonia, Pneumocystis carinii","Pentamidine","Infusions, Intravenous","Leucovorin","Drug Therapy, Combination","Folic Acid Antagonists","Aerosols","Acquired Immunodeficiency Syndrome","Antiprotozoal Agents","AIDS-Related Complex","COMPLETED","2021-10-28",{"date":262,"type":263},"2021-11-04","ACTUAL",{"date":265,"type":263},"1991-09",{"name":5,"class":6},23]