[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054943":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":14,"centralContacts":7,"locations":17,"responsibleParty":7,"collaborators":7,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":7,"eligibilityCriteria":204,"healthyVolunteers":201,"sex":205,"minAge":206,"maxAge":7,"enrollmentInfo":207,"targetDuration":7,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":218,"whyStopped":7,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":7,"completionDateStruct":223,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Bristol-Myers 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Haven","Connecticut","06510",{"type":26,"coordinates":37},[38,39],-72.92816,41.30815,{"lat":39,"lon":38},{"facility":42,"status":7,"city":43,"state":44,"zip":45,"country":23,"countryCode":24,"cosmosGeoPoint":46,"geoPoint":50,"contacts":7},"G E Morey Jr","Fort Lauderdale","Florida","33316",{"type":26,"coordinates":47},[48,49],-80.14338,26.12231,{"lat":49,"lon":48},{"facility":52,"status":7,"city":53,"state":44,"zip":54,"country":23,"countryCode":24,"cosmosGeoPoint":55,"geoPoint":59,"contacts":7},"VP Med Services \u002F HHCS Research Institute Inc","Orlando","32806",{"type":26,"coordinates":56},[57,58],-81.37924,28.53834,{"lat":58,"lon":57},{"facility":61,"status":7,"city":62,"state":63,"zip":64,"country":23,"countryCode":24,"cosmosGeoPoint":65,"geoPoint":69,"contacts":7},"AIDS Research Consortium of Atlanta","Atlanta","Georgia","30308",{"type":26,"coordinates":66},[67,68],-84.38798,33.749,{"lat":68,"lon":67},{"facility":71,"status":7,"city":72,"state":73,"zip":74,"country":23,"countryCode":24,"cosmosGeoPoint":75,"geoPoint":79,"contacts":7},"Edward Hines Veterans Administration Hosp","Hines","Illinois","60141",{"type":26,"coordinates":76},[77,78],-87.8395,41.85364,{"lat":78,"lon":77},{"facility":81,"status":7,"city":82,"state":83,"zip":84,"country":23,"countryCode":24,"cosmosGeoPoint":85,"geoPoint":89,"contacts":7},"Univ of Kansas School of Medicine","Wichita","Kansas","67214",{"type":26,"coordinates":86},[87,88],-97.33754,37.69224,{"lat":88,"lon":87},{"facility":91,"status":7,"city":92,"state":93,"zip":94,"country":23,"countryCode":24,"cosmosGeoPoint":95,"geoPoint":99,"contacts":7},"Harper Hosp","Detroit","Michigan","48201",{"type":26,"coordinates":96},[97,98],-83.04575,42.33143,{"lat":98,"lon":97},{"facility":101,"status":7,"city":102,"state":103,"zip":104,"country":23,"countryCode":24,"cosmosGeoPoint":105,"geoPoint":109,"contacts":7},"Albany Med College \u002F AIDS Treatment Ctr","Albany","New York","12203",{"type":26,"coordinates":106},[107,108],-73.75623,42.65258,{"lat":108,"lon":107},{"facility":111,"status":7,"city":112,"state":113,"zip":114,"country":23,"countryCode":24,"cosmosGeoPoint":115,"geoPoint":119,"contacts":7},"Med College of Ohio","Toledo","Ohio","43699",{"type":26,"coordinates":116},[117,118],-83.55521,41.66394,{"lat":118,"lon":117},{"facility":121,"status":7,"city":122,"state":123,"zip":124,"country":23,"countryCode":24,"cosmosGeoPoint":125,"geoPoint":129,"contacts":7},"Univ of Pennsylvania \u002F HIV 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Antonio","78284",{"type":26,"coordinates":154},[155,156],-98.49363,29.42412,{"lat":156,"lon":155},{"facility":159,"status":7,"city":160,"state":161,"zip":162,"country":23,"countryCode":24,"cosmosGeoPoint":163,"geoPoint":167,"contacts":7},"Univ of Utah School of Medicine","Salt Lake City","Utah","84132",{"type":26,"coordinates":164},[165,166],-111.89105,40.76078,{"lat":166,"lon":165},{"facility":169,"status":7,"city":170,"state":171,"zip":172,"country":23,"countryCode":24,"cosmosGeoPoint":173,"geoPoint":177,"contacts":7},"Dr Stephen L Green","Hampton","Virginia","23666",{"type":26,"coordinates":174},[175,176],-76.34522,37.02987,{"lat":176,"lon":175},{"facility":179,"status":7,"city":180,"state":181,"zip":182,"country":23,"countryCode":24,"cosmosGeoPoint":183,"geoPoint":187,"contacts":7},"Milwaukee County Med Complex","Milwaukee","Wisconsin","53226",{"type":26,"coordinates":184},[185,186],-87.90647,43.0389,{"lat":186,"lon":185},{"facility":189,"status":7,"city":190,"state":7,"zip":191,"country":192,"countryCode":193,"cosmosGeoPoint":194,"geoPoint":198,"contacts":7},"UPR School of Medicine","San Juan","009275800","Puerto Rico","PR",{"type":26,"coordinates":195},[196,197],-66.10572,18.46633,{"lat":197,"lon":196},"100054943","double-blind-comparison-of-the-efficacy-of-continued-zidovudine-versus-23-dideoxyinosine-ddi-bmy-40900-for-the-treatment-of-patients-with-aids-or-aids-related-complex-and-increasing-symptomatology-despite-treatment-with-zidovudine-100054943",false,"NCT00002035","Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed for Hematologic toxicity:\n\n* Erythropoietin.\n* Colony-Stimulating Factors.\n* Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):\n* Aerosolized pentamidine.\n* Trimethoprim\u002Fsulfamethoxazole.\n* Dapsone.\n* NOTE:\n* If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine.\n* Allowed:\n* Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol).\n\nConcurrent Treatment:\n\nAllowed:\n\n* Transfusions for hematologic toxicity.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Active acute AIDS defining infection.\n* Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.\n* Dementia of such severity that patient cannot give informed consent.\n* Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).\n* Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.\n* Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy.\n* Cardiomyopathy or the need for antiarrhythmic therapy.\n* Inability to tolerate at least 600 mg per day of zidovudine (AZT).\n* Seizures within the last 6 months or the need for anticonvulsant therapy.\n\nConcurrent Medication:\n\nExcluded:\n\n* Ganciclovir (DHPG).\n* Myelosuppressive or neurotoxic chemotherapy.\n* Antiarrhythmic therapy.\n* Anticonvulsant therapy.\n* Neurotoxic agents (as defined in the protocol).\n* NOTE:\n* If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine.\n\nPatients with the following are excluded:\n\n* Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field.\n* Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry \\> 300 cells\u002Fmm3.\n\nPrior Medication:\n\nExcluded, participation in studies using:\n\n* Dideoxyinosine (ddI).\n* 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T).\n* Dideoxycytidine (ddC).\n* Excluded within one month of study entry:\n* Any other experimental antiretroviral compounds.\n\nPatients must:\n\n* Have documented HIV positivity via ELISA.\n* Meet CDC criteria for AIDS or AIDS related complex (ARC).\n* Have received zidovudine (AZT) for = or \\> 6 months and tolerated a dose of at least 500 mg per day without significant hematologic toxicity.\n* Have no acute AIDS defining opportunistic infection, but may be receiving suppressive therapy for such infections.\n* Demonstrate at least one of the following criteria for clinical deterioration despite AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss):\n* involuntary weight loss of more than 5 percent of the body weight occurring over the 8 week period prior to study entry, Karnofsky score = or \\> 50 but demonstrating a fall = or \\> 20 from previous level of functioning (assessment must be persistent on two occasions at least 14 days apart), unexplained fever of = or \\> 38 degrees C (despite evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent multidermatomal varicella-zoster, appearance of dermatologic afflictions (e.g. psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis), appearance of chronic herpetic ulcers not responsive to acyclovir therapy.\n\nRequired:\n\n* Zidovudine (AZT) for = or \\> 6 months prior to study entry.","ALL","12 Years",{"count":208,"type":7},300,"INTERVENTIONAL",[211],"NA","To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.",[214],"HIV Infections",[13,216,217,11],"Acquired Immunodeficiency Syndrome","AIDS-Related Complex","COMPLETED","2011-08-04",{"date":221,"type":222},"2011-08-05","ESTIMATED",{"date":224,"type":225},"1992-04","ACTUAL",{"name":5,"class":6},18]