[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100055296":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":16,"responsibleParty":7,"collaborators":7,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":7,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":7,"enrollmentInfo":174,"targetDuration":7,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":192,"whyStopped":7,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":197,"locationsCount":199},{"fullName":5,"class":6},"NIH AIDS Clinical Trials Information Service","INDUSTRY",null,[9,12,14],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Abacavir sulfate",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Lamivudine",{"type":10,"name":15,"description":7,"armGroupLabels":7,"otherNames":7},"Zidovudine",[17,30,39,49,59,69,79,89,98,104,114,124,134,143,154],{"facility":18,"status":7,"city":19,"state":20,"zip":21,"country":22,"countryCode":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":7},"East Bay AIDS Ctr","Berkeley","California","94705","United States","US",{"type":25,"coordinates":26},"Point",[27,28],-122.27275,37.87159,{"lat":28,"lon":27},{"facility":31,"status":7,"city":32,"state":20,"zip":33,"country":22,"countryCode":23,"cosmosGeoPoint":34,"geoPoint":38,"contacts":7},"Kraus Med Partners","Los Angeles","90036",{"type":25,"coordinates":35},[36,37],-118.24368,34.05223,{"lat":37,"lon":36},{"facility":40,"status":7,"city":41,"state":42,"zip":43,"country":22,"countryCode":23,"cosmosGeoPoint":44,"geoPoint":48,"contacts":7},"Georgetown Univ Med Ctr","Washington D.C.","District of Columbia","20007",{"type":25,"coordinates":45},[46,47],-77.03637,38.89511,{"lat":47,"lon":46},{"facility":50,"status":7,"city":51,"state":52,"zip":53,"country":22,"countryCode":23,"cosmosGeoPoint":54,"geoPoint":58,"contacts":7},"Univ of Miami Dept of Medicine","Miami","Florida","33136",{"type":25,"coordinates":55},[56,57],-80.19366,25.77427,{"lat":57,"lon":56},{"facility":60,"status":7,"city":61,"state":62,"zip":63,"country":22,"countryCode":23,"cosmosGeoPoint":64,"geoPoint":68,"contacts":7},"Rush Med College \u002F Rush Presbyterian - St Luke's Med Cen","Chicago","Illinois","60612",{"type":25,"coordinates":65},[66,67],-87.65005,41.85003,{"lat":67,"lon":66},{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":22,"countryCode":23,"cosmosGeoPoint":74,"geoPoint":78,"contacts":7},"Boston Med Ctr \u002F Evans - 556","Boston","Massachusetts","021182393",{"type":25,"coordinates":75},[76,77],-71.05977,42.35843,{"lat":77,"lon":76},{"facility":80,"status":7,"city":81,"state":82,"zip":83,"country":22,"countryCode":23,"cosmosGeoPoint":84,"geoPoint":88,"contacts":7},"Saint Michael's Med Ctr \u002F Dept of Infectious Diseases","Newark","New Jersey","07102",{"type":25,"coordinates":85},[86,87],-74.17237,40.73566,{"lat":87,"lon":86},{"facility":90,"status":7,"city":91,"state":91,"zip":92,"country":22,"countryCode":23,"cosmosGeoPoint":93,"geoPoint":97,"contacts":7},"St Vincent's Hosp and Med Ctr \u002F AIDS Ctr","New York","10011",{"type":25,"coordinates":94},[95,96],-74.00597,40.71427,{"lat":96,"lon":95},{"facility":99,"status":7,"city":91,"state":91,"zip":100,"country":22,"countryCode":23,"cosmosGeoPoint":101,"geoPoint":103,"contacts":7},"Harlem Hosp","10027",{"type":25,"coordinates":102},[95,96],{"lat":96,"lon":95},{"facility":105,"status":7,"city":106,"state":107,"zip":108,"country":22,"countryCode":23,"cosmosGeoPoint":109,"geoPoint":113,"contacts":7},"Duke Univ Med Ctr \u002F Dept of Medicine","Durham","North Carolina","27710",{"type":25,"coordinates":110},[111,112],-78.89862,35.99403,{"lat":112,"lon":111},{"facility":115,"status":7,"city":116,"state":117,"zip":118,"country":22,"countryCode":23,"cosmosGeoPoint":119,"geoPoint":123,"contacts":7},"Univ of Cincinnati \u002F Holmes Hosp","Cincinnati","Ohio","452670405",{"type":25,"coordinates":120},[121,122],-84.51439,39.12711,{"lat":122,"lon":121},{"facility":125,"status":7,"city":126,"state":127,"zip":128,"country":22,"countryCode":23,"cosmosGeoPoint":129,"geoPoint":133,"contacts":7},"Dr Nicholaos Bellos","Dallas","Texas","75225",{"type":25,"coordinates":130},[131,132],-96.80667,32.78306,{"lat":132,"lon":131},{"facility":135,"status":7,"city":136,"state":127,"zip":137,"country":22,"countryCode":23,"cosmosGeoPoint":138,"geoPoint":142,"contacts":7},"Baylor College of Medicine \u002F Dept of Medicine","Houston","770303498",{"type":25,"coordinates":139},[140,141],-95.36327,29.76328,{"lat":141,"lon":140},{"facility":144,"status":7,"city":145,"state":146,"zip":7,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":7},"Toronto Gen Hosp","Toronto","Ontario","Canada","CA",{"type":25,"coordinates":150},[151,152],-79.39864,43.70643,{"lat":152,"lon":151},{"facility":155,"status":7,"city":156,"state":7,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":7},"San Juan AIDS Program","Santurce","00907","Puerto Rico","PR",{"type":25,"coordinates":161},[162,163],-67.14018,18.19523,{"lat":163,"lon":162},"100055296","phase-3-the-safety-and-effectiveness-of-lamivudine-plus-zidovudine-used-with-and-without-1592u89-in-hiv-1-infected-patients-who-have-never-taken-anti-hiv-drugs-100055296",false,"NCT00002389","The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs","A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine (3TC) and Zidovudine (ZDV) Versus 3TC\u002FZDV in HIV-1-Infected, Antiretroviral Therapy-Naive Subjects With CD4+ Counts >= 100 Cells\u002Fmm3","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Local treatment for Kaposi's sarcoma.\n* Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.\n\nPatients must have:\n\n* HIV-1 infection as documented by a licensed HIV-1 antibody ELISA and confirmed by either Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.\n* One screening CD4 lymphocyte cell count \\>= 100 cells\u002Fmm3 within 14 days prior to study drug administration.\n* No active or ongoing AIDS-defining opportunistic infection or disease.\n* Signed, informed consent from parent or legal guardian for patients under 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions and symptoms are excluded:\n\n* Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.\n* Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that, in the opinion of the investigator, would compromise the safety of the patient.\n\nConcurrent Medication:\n\nExcluded:\n\n* Foscarnet therapy.\n* Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents, or interferons.\n* Cytotoxic chemotherapeutic agents and antioxidants.\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiation therapy.\n\nPatients with the following prior conditions are excluded:\n\nHistory of clinically relevant pancreatitis or hepatitis within the last 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Prior antiretroviral therapy.\n* Vaccination within the past 3 months given as part of an investigational HIV vaccine trial.\n* Chemotherapeutic agents within 30 days of study drug administration.\n* Immunomodulating agents such as systemic corticosteroids, interleukins or interferons, within 30 days of study drug administration.\n\nPrior Treatment:\n\nExcluded:\n\nRadiation therapy within 30 days of study period. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.","ALL","13 Years",{"count":175,"type":7},210,"INTERVENTIONAL",[178],"PHASE3","To compare the durability of the viral load response following 48 weeks of treatment with 1592U89\u002Flamivudine (3TC)\u002Fzidovudine (ZDV) versus 3TC\u002FZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89\u002F3TC\u002FZDV versus 3TC\u002FZDV alone as demonstrated by the proportion of subjects with viral load \\\u003C 400 copies\u002Fml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89\u002F3TC\u002FZDV versus 3TC\u002FZDV alone.",[181],"HIV Infections",[183,184,185,15,186,13,187,188,189,190,191],"HIV-1","Drug Therapy, Combination","Antiviral Agents","CD4 Lymphocyte Count","RNA, Viral","Reverse Transcriptase Inhibitors","Anti-HIV Agents","Viral Load","abacavir","COMPLETED","2005-06-23",{"date":195,"type":196},"2005-06-24","ESTIMATED",{"name":198,"class":6},"Glaxo Wellcome",15]