[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053742":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":16,"responsibleParty":316,"collaborators":318,"id":322,"slug":323,"hasResults":324,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":7,"eligibilityCriteria":327,"healthyVolunteers":324,"sex":328,"minAge":329,"maxAge":330,"enrollmentInfo":331,"targetDuration":7,"studyType":333,"phases":334,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":343,"whyStopped":7,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":7,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Zalcitabine",[13],{"name":14,"affiliation":7,"role":15},"Spector SA","STUDY_CHAIR",[17,30,39,48,57,67,77,87,97,102,108,117,122,132,138,148,154,163,172,181,191,199,208,216,222,228,234,243,252,262,271,281,291,302,311],{"facility":18,"status":7,"city":19,"state":20,"zip":21,"country":22,"countryCode":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":7},"UCLA-Los Angeles\u002FBrazil AIDS Consortium (LABAC) CRS","Los Angeles","California","90095","United States","US",{"type":25,"coordinates":26},"Point",[27,28],-118.24368,34.05223,{"lat":28,"lon":27},{"facility":31,"status":7,"city":32,"state":20,"zip":33,"country":22,"countryCode":23,"cosmosGeoPoint":34,"geoPoint":38,"contacts":7},"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.","Oakland","94609",{"type":25,"coordinates":35},[36,37],-122.2708,37.80437,{"lat":37,"lon":36},{"facility":40,"status":7,"city":41,"state":20,"zip":42,"country":22,"countryCode":23,"cosmosGeoPoint":43,"geoPoint":47,"contacts":7},"UCSD Maternal, Child, and Adolescent HIV CRS","San Diego","92093",{"type":25,"coordinates":44},[45,46],-117.16472,32.71571,{"lat":46,"lon":45},{"facility":49,"status":7,"city":50,"state":20,"zip":51,"country":22,"countryCode":23,"cosmosGeoPoint":52,"geoPoint":56,"contacts":7},"UCSF Pediatric AIDS CRS","San Francisco","94143",{"type":25,"coordinates":53},[54,55],-122.41942,37.77493,{"lat":55,"lon":54},{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":22,"countryCode":23,"cosmosGeoPoint":62,"geoPoint":66,"contacts":7},"Children's National Med. Ctr., ACTU","Washington D.C.","District of Columbia","20010",{"type":25,"coordinates":63},[64,65],-77.03637,38.89511,{"lat":65,"lon":64},{"facility":68,"status":7,"city":69,"state":70,"zip":71,"country":22,"countryCode":23,"cosmosGeoPoint":72,"geoPoint":76,"contacts":7},"Univ. of Miami Ped. Perinatal HIV\u002FAIDS CRS","Miami","Florida","33161",{"type":25,"coordinates":73},[74,75],-80.19366,25.77427,{"lat":75,"lon":74},{"facility":78,"status":7,"city":79,"state":80,"zip":81,"country":22,"countryCode":23,"cosmosGeoPoint":82,"geoPoint":86,"contacts":7},"Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases","Atlanta","Georgia","30303",{"type":25,"coordinates":83},[84,85],-84.38798,33.749,{"lat":85,"lon":84},{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":22,"countryCode":23,"cosmosGeoPoint":92,"geoPoint":96,"contacts":7},"Cook County Hosp.","Chicago","Illinois","60612",{"type":25,"coordinates":93},[94,95],-87.65005,41.85003,{"lat":95,"lon":94},{"facility":98,"status":7,"city":89,"state":90,"zip":91,"country":22,"countryCode":23,"cosmosGeoPoint":99,"geoPoint":101,"contacts":7},"Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.",{"type":25,"coordinates":100},[94,95],{"lat":95,"lon":94},{"facility":103,"status":7,"city":89,"state":90,"zip":104,"country":22,"countryCode":23,"cosmosGeoPoint":105,"geoPoint":107,"contacts":7},"Chicago Children's CRS","60614",{"type":25,"coordinates":106},[94,95],{"lat":95,"lon":94},{"facility":109,"status":7,"city":110,"state":111,"zip":7,"country":22,"countryCode":23,"cosmosGeoPoint":112,"geoPoint":116,"contacts":7},"Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU","New Orleans","Louisiana",{"type":25,"coordinates":113},[114,115],-90.07507,29.95465,{"lat":115,"lon":114},{"facility":118,"status":7,"city":110,"state":111,"zip":7,"country":22,"countryCode":23,"cosmosGeoPoint":119,"geoPoint":121,"contacts":7},"Tulane\u002FLSU Maternal\u002FChild CRS",{"type":25,"coordinates":120},[114,115],{"lat":115,"lon":114},{"facility":123,"status":7,"city":124,"state":125,"zip":126,"country":22,"countryCode":23,"cosmosGeoPoint":127,"geoPoint":131,"contacts":7},"Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology","Baltimore","Maryland","21201",{"type":25,"coordinates":128},[129,130],-76.61219,39.29038,{"lat":130,"lon":129},{"facility":133,"status":7,"city":124,"state":125,"zip":134,"country":22,"countryCode":23,"cosmosGeoPoint":135,"geoPoint":137,"contacts":7},"Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases","21287",{"type":25,"coordinates":136},[129,130],{"lat":130,"lon":129},{"facility":139,"status":7,"city":140,"state":141,"zip":142,"country":22,"countryCode":23,"cosmosGeoPoint":143,"geoPoint":147,"contacts":7},"HMS - Children's Hosp. Boston, Div. of Infectious Diseases","Boston","Massachusetts","02115",{"type":25,"coordinates":144},[145,146],-71.05977,42.35843,{"lat":146,"lon":145},{"facility":149,"status":7,"city":140,"state":141,"zip":150,"country":22,"countryCode":23,"cosmosGeoPoint":151,"geoPoint":153,"contacts":7},"BMC, Div. of Ped Infectious Diseases","02118",{"type":25,"coordinates":152},[145,146],{"lat":146,"lon":145},{"facility":155,"status":7,"city":156,"state":141,"zip":157,"country":22,"countryCode":23,"cosmosGeoPoint":158,"geoPoint":162,"contacts":7},"Baystate Health, Baystate Med. Ctr.","Springfield","01199",{"type":25,"coordinates":159},[160,161],-72.58981,42.10148,{"lat":161,"lon":160},{"facility":164,"status":7,"city":165,"state":141,"zip":166,"country":22,"countryCode":23,"cosmosGeoPoint":167,"geoPoint":171,"contacts":7},"WNE Maternal Pediatric Adolescent AIDS CRS","Worcester","01655",{"type":25,"coordinates":168},[169,170],-71.80229,42.26259,{"lat":170,"lon":169},{"facility":173,"status":7,"city":174,"state":175,"zip":7,"country":22,"countryCode":23,"cosmosGeoPoint":176,"geoPoint":180,"contacts":7},"UMDNJ - Robert Wood Johnson","New Brunswick","New Jersey",{"type":25,"coordinates":177},[178,179],-74.45182,40.48622,{"lat":179,"lon":178},{"facility":182,"status":7,"city":183,"state":184,"zip":185,"country":22,"countryCode":23,"cosmosGeoPoint":186,"geoPoint":190,"contacts":7},"SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS","Brooklyn","New York","11203",{"type":25,"coordinates":187},[188,189],-73.94958,40.6501,{"lat":189,"lon":188},{"facility":192,"status":7,"city":193,"state":184,"zip":7,"country":22,"countryCode":23,"cosmosGeoPoint":194,"geoPoint":198,"contacts":7},"North Shore-Long Island Jewish Health System, Dept. of Peds.","Great Neck",{"type":25,"coordinates":195},[196,197],-73.72846,40.80066,{"lat":197,"lon":196},{"facility":200,"status":7,"city":201,"state":184,"zip":202,"country":22,"countryCode":23,"cosmosGeoPoint":203,"geoPoint":207,"contacts":7},"Schneider Children's Hosp., Div. of Infectious Diseases","New Hyde Park","11042",{"type":25,"coordinates":204},[205,206],-73.68791,40.7351,{"lat":206,"lon":205},{"facility":209,"status":7,"city":184,"state":184,"zip":210,"country":22,"countryCode":23,"cosmosGeoPoint":211,"geoPoint":215,"contacts":7},"NYU Med. Ctr., Dept. of Medicine","10016",{"type":25,"coordinates":212},[213,214],-74.00597,40.71427,{"lat":214,"lon":213},{"facility":217,"status":7,"city":184,"state":184,"zip":218,"country":22,"countryCode":23,"cosmosGeoPoint":219,"geoPoint":221,"contacts":7},"Metropolitan Hosp. NICHD CRS","10029",{"type":25,"coordinates":220},[213,214],{"lat":214,"lon":213},{"facility":223,"status":7,"city":184,"state":184,"zip":224,"country":22,"countryCode":23,"cosmosGeoPoint":225,"geoPoint":227,"contacts":7},"Columbia IMPAACT CRS","10032",{"type":25,"coordinates":226},[213,214],{"lat":214,"lon":213},{"facility":229,"status":7,"city":184,"state":184,"zip":230,"country":22,"countryCode":23,"cosmosGeoPoint":231,"geoPoint":233,"contacts":7},"Harlem Hosp. Ctr. NY NICHD CRS","10037",{"type":25,"coordinates":232},[213,214],{"lat":214,"lon":213},{"facility":235,"status":7,"city":236,"state":184,"zip":237,"country":22,"countryCode":23,"cosmosGeoPoint":238,"geoPoint":242,"contacts":7},"Univ. of Rochester ACTG CRS","Rochester","14642",{"type":25,"coordinates":239},[240,241],-77.61556,43.15478,{"lat":241,"lon":240},{"facility":244,"status":7,"city":245,"state":184,"zip":246,"country":22,"countryCode":23,"cosmosGeoPoint":247,"geoPoint":251,"contacts":7},"Bronx-Lebanon Hosp. IMPAACT CRS","The Bronx","10456",{"type":25,"coordinates":248},[249,250],-73.86641,40.84985,{"lat":250,"lon":249},{"facility":253,"status":7,"city":254,"state":255,"zip":256,"country":22,"countryCode":23,"cosmosGeoPoint":257,"geoPoint":261,"contacts":7},"UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases","Chapel Hill","North Carolina","27599",{"type":25,"coordinates":258},[259,260],-79.05584,35.9132,{"lat":260,"lon":259},{"facility":263,"status":7,"city":264,"state":255,"zip":265,"country":22,"countryCode":23,"cosmosGeoPoint":266,"geoPoint":270,"contacts":7},"DUMC Ped. CRS","Durham","27710",{"type":25,"coordinates":267},[268,269],-78.89862,35.99403,{"lat":269,"lon":268},{"facility":272,"status":7,"city":273,"state":274,"zip":275,"country":22,"countryCode":23,"cosmosGeoPoint":276,"geoPoint":280,"contacts":7},"St. Christopher's Hosp. for Children","Philadelphia","Pennsylvania","19134",{"type":25,"coordinates":277},[278,279],-75.16362,39.95238,{"lat":279,"lon":278},{"facility":282,"status":7,"city":283,"state":284,"zip":285,"country":22,"countryCode":23,"cosmosGeoPoint":286,"geoPoint":290,"contacts":7},"Texas Children's Hosp. CRS","Houston","Texas","77030",{"type":25,"coordinates":287},[288,289],-95.36327,29.76328,{"lat":289,"lon":288},{"facility":292,"status":7,"city":293,"state":7,"zip":294,"country":295,"countryCode":296,"cosmosGeoPoint":297,"geoPoint":301,"contacts":7},"Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.","Bayamón","00619","Puerto Rico","PR",{"type":25,"coordinates":298},[299,300],-66.15572,18.39856,{"lat":300,"lon":299},{"facility":303,"status":7,"city":304,"state":7,"zip":305,"country":295,"countryCode":296,"cosmosGeoPoint":306,"geoPoint":310,"contacts":7},"Univ. of Puerto Rico Ped. HIV\u002FAIDS Research Program CRS","San Juan","00936",{"type":25,"coordinates":307},[308,309],-66.10572,18.46633,{"lat":309,"lon":308},{"facility":312,"status":7,"city":304,"state":7,"zip":7,"country":295,"countryCode":296,"cosmosGeoPoint":313,"geoPoint":315,"contacts":7},"San Juan City Hosp. PR NICHD CRS",{"type":25,"coordinates":314},[308,309],{"lat":309,"lon":308},{"type":317,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[319],{"name":320,"class":321},"Hoffmann-La Roche","INDUSTRY","100053742","phase-2-a-trial-of-two-doses-of-23-dideoxycytidine-ddc-in-the-treatment-of-children-with-symptomatic-hiv-infection-who-are-intolerant-of-azt-andor-who-show-progressive-disease-while-on-azt-100053742",false,"NCT00000653","A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and\u002For Who Show Progressive Disease While on AZT","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Procrit.\n* Amphotericin B (1 mg\u002Fkg up to 5 days\u002Fweek).\n* Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia.\n* Acyclovir (up to 1000 mg\u002Fday PO; for \\> 1000 mg\u002Fday PO or for any IV dose, suggest interrupting ddC).\n* Ketoconazole (up to 10 mg\u002Fkg\u002Fday).\n* Nystatin.\n* Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours).\n* Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25\n* 50 mg\u002Fday to avoid possible INH-associated neuropathy.\n* Trimethoprim \u002F sulfamethoxazole (T\u002FS).\n* Immunoglobulin therapy.\n* Aerosolized pentamidine.\n* Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Immunoglobulin therapy.\n* Nutritional support (for children with wasting syndrome and\u002For malnutritional) including hyperalimentation (TPN) of dietary supplements.\n\nAMENDED:\n\n* Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study.\n\nORIGINAL design:\n\n* Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol.\n\nPatients must have the following:\n\n* Absence of acute opportunistic infection at time of entry.\n* However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for \\> 4 weeks are eligible.\n* Parent or guardian available to give written informed consent.\n\nAllowed at time of study entry:\n\n* Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP).\n* Immunoglobulin therapy.\n\nPrior Medication:\n\nAMENDED:\n\n* AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry\n\nAllowed:\n\n* Zidovudine (AZT) within 4 weeks of entry.\n* Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI.\n* Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC.\n* Vitamin, folate, iron supplements.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nAMENDED:\n\n* 04-25-91 Additional excluded symptoms and conditions:\n* Symptomatic cardiomyopathy.\n* Seizures which are not well controlled by ongoing anticonvulsant therapy.\n* Active malignancy requiring concomitant chemotherapy.\n* Symptomatic pancreatitis.\n* Grade I or greater peripheral neuropathy.\n* Receiving concomitant zidovudine (AZT).\n* Patients with the following conditions or symptoms are excluded:\n* Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.\n* Known hypersensitivity to dideoxycytidine (ddC).\n\nConcurrent Medication:\n\nExcluded:\n\n* Other antiviral agents, biological modifiers, and investigational medications.\n* Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin.\n\nPatients with the following are excluded:\n\n* Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.\n* Known hypersensitivity to dideoxycytidine (ddC).\n* Active opportunistic infection requiring treatment with an excluded concomitant medication.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry.\n* Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.\n* Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.","ALL","3 Months","18 Years",{"count":332,"type":7},140,"INTERVENTIONAL",[335],"PHASE2","To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.\n\nAs useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.",[338],"HIV Infections",[11,340,341,342],"Drug Evaluation","Acquired Immunodeficiency Syndrome","AIDS-Related Complex","COMPLETED","2021-10-26",{"date":346,"type":347},"2021-10-27","ACTUAL",{"date":349,"type":347},"1995-06",{"name":5,"class":6},35]