[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100055278":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":18,"responsibleParty":7,"collaborators":7,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":7,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":7,"enrollmentInfo":107,"targetDuration":7,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":121,"whyStopped":7,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",null,[9,12,14,16],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Indinavir sulfate",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Lamivudine",{"type":10,"name":15,"description":7,"armGroupLabels":7,"otherNames":7},"Stavudine",{"type":10,"name":17,"description":7,"armGroupLabels":7,"otherNames":7},"Zidovudine",[19,32,42,52,62,72,78,87],{"facility":20,"status":7,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":7},"Harbor UCLA Med Ctr","Torrance","California","90502","United States","US",{"type":27,"coordinates":28},"Point",[29,30],-118.34063,33.83585,{"lat":30,"lon":29},{"facility":33,"status":7,"city":34,"state":35,"zip":36,"country":24,"countryCode":25,"cosmosGeoPoint":37,"geoPoint":41,"contacts":7},"Univ of South Florida","Tampa","Florida","33612",{"type":27,"coordinates":38},[39,40],-82.45843,27.94752,{"lat":40,"lon":39},{"facility":43,"status":7,"city":44,"state":45,"zip":46,"country":24,"countryCode":25,"cosmosGeoPoint":47,"geoPoint":51,"contacts":7},"SUNY at Stony Brook \u002F Division of Infectious Diseases","Stony Brook","New York","11794",{"type":27,"coordinates":48},[49,50],-73.14094,40.92565,{"lat":50,"lon":49},{"facility":53,"status":7,"city":54,"state":55,"zip":56,"country":24,"countryCode":25,"cosmosGeoPoint":57,"geoPoint":61,"contacts":7},"Houston Clinical Research Network \u002F Div of Montrose Clinic","Houston","Texas","77006",{"type":27,"coordinates":58},[59,60],-95.36327,29.76328,{"lat":60,"lon":59},{"facility":63,"status":7,"city":64,"state":65,"zip":66,"country":24,"countryCode":25,"cosmosGeoPoint":67,"geoPoint":71,"contacts":7},"Univ of Utah \u002F School of Medicine \u002F Div of Infect Dis","Salt Lake City","Utah","84132",{"type":27,"coordinates":68},[69,70],-111.89105,40.76078,{"lat":70,"lon":69},{"facility":73,"status":7,"city":74,"state":75,"zip":7,"country":76,"countryCode":77,"cosmosGeoPoint":7,"geoPoint":7,"contacts":7},"Sunnybrook Health Science Ctr","North York","Ontario","Canada","CA",{"facility":79,"status":7,"city":80,"state":81,"zip":7,"country":76,"countryCode":77,"cosmosGeoPoint":82,"geoPoint":86,"contacts":7},"Montreal Gen Hosp \u002F Div of Clin Immuno and Allergy","Montreal","Quebec",{"type":27,"coordinates":83},[84,85],-73.58781,45.50884,{"lat":85,"lon":84},{"facility":88,"status":7,"city":89,"state":7,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":7},"Univ of Puerto Rico School of Medicine","San Juan","00927","Puerto Rico","PR",{"type":27,"coordinates":94},[95,96],-66.10572,18.46633,{"lat":96,"lon":95},"100055278","phase-3-the-safety-and-effectiveness-of-lamivudine-plus-stavudine-or-zidovudine-in-hiv-infected-patients-who-have-taken-zidovudine-100055278",false,"NCT00002371","The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine","A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy","Inclusion Criteria\n\nPatients must have:\n\n* At least six months of prior cumulative ZDV therapy.\n* Qualifying plasma HIV RNA count of \\>= 4 log10 copies\u002Fml obtained within 2 weeks of randomization.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with any of the following symptoms or conditions are excluded:\n\n* Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.\n* Intractable diarrhea (\\>= 6 loose stools\u002Fday for \\>= 7 consecutive days).\n* Signs and symptoms of bilateral peripheral neuropathy \\>= grade 2 at the time of screening.\n* Inability to tolerate oral medication.\n* Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.\n* Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.\n\nPatients with any of the following prior conditions or symptoms are excluded:\n\n* History of acute or chronic pancreatitis.\n* Prior history of bilateral peripheral neuropathy.\n* Intractable diarrhea (\\>= 6 loose stools\u002Fday for \\>= 7 consecutive days) within 30 days prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria).\n* Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.\n* Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.\n* Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.\n\nRisk Behavior:\n\nExcluded:\n\n* Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.\n\nRequired:\n\nAt least 6 months of prior cumulative ZDV therapy.","ALL","18 Years",{"count":108,"type":7},80,"INTERVENTIONAL",[111],"PHASE3","To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.",[114],"HIV Infections",[116,117,15,13,118,119,120],"HIV-1","Drug Therapy, Combination","RNA, Viral","Anti-HIV Agents","Viral Load","COMPLETED","2011-04-28",{"date":124,"type":125},"2011-05-04","ESTIMATED",{"date":127,"type":7},"1996-06",{"date":129,"type":130},"1997-12","ACTUAL",{"name":5,"class":6},8]