[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100055286":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":22,"responsibleParty":7,"collaborators":7,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":7,"eligibilityCriteria":177,"healthyVolunteers":173,"sex":178,"minAge":179,"maxAge":7,"enrollmentInfo":180,"targetDuration":7,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":200,"whyStopped":7,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":205,"locationsCount":207},{"fullName":5,"class":6},"NIH AIDS Clinical Trials Information Service","INDUSTRY",null,[9,12,14,16,18,20],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Indinavir sulfate",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Levocarnitine",{"type":10,"name":15,"description":7,"armGroupLabels":7,"otherNames":7},"Adefovir dipivoxil",{"type":10,"name":17,"description":7,"armGroupLabels":7,"otherNames":7},"Lamivudine",{"type":10,"name":19,"description":7,"armGroupLabels":7,"otherNames":7},"Stavudine",{"type":10,"name":21,"description":7,"armGroupLabels":7,"otherNames":7},"Zidovudine",[23,36,46,55,65,75,85,95,105,114,120,130,140,150,160],{"facility":24,"status":7,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":7},"Phoenix Body Positive","Phoenix","Arizona","85016","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-112.07404,33.44838,{"lat":34,"lon":33},{"facility":37,"status":7,"city":38,"state":39,"zip":40,"country":28,"countryCode":29,"cosmosGeoPoint":41,"geoPoint":45,"contacts":7},"AIDS Healthcare Foundation Labs","Los Angeles","California","90027",{"type":31,"coordinates":42},[43,44],-118.24368,34.05223,{"lat":44,"lon":43},{"facility":47,"status":7,"city":48,"state":39,"zip":49,"country":28,"countryCode":29,"cosmosGeoPoint":50,"geoPoint":54,"contacts":7},"Davies Med Ctr","San Francisco","94114",{"type":31,"coordinates":51},[52,53],-122.41942,37.77493,{"lat":53,"lon":52},{"facility":56,"status":7,"city":57,"state":58,"zip":59,"country":28,"countryCode":29,"cosmosGeoPoint":60,"geoPoint":64,"contacts":7},"Blick Med Associates","Greenwich","Connecticut","06830",{"type":31,"coordinates":61},[62,63],-73.62846,41.02649,{"lat":63,"lon":62},{"facility":66,"status":7,"city":67,"state":68,"zip":69,"country":28,"countryCode":29,"cosmosGeoPoint":70,"geoPoint":74,"contacts":7},"George Washington Med Ctr","Washington D.C.","District of Columbia","20037",{"type":31,"coordinates":71},[72,73],-77.03637,38.89511,{"lat":73,"lon":72},{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":28,"countryCode":29,"cosmosGeoPoint":80,"geoPoint":84,"contacts":7},"Cook County Gen Hosp \u002F Division of Infect Diseases","Chicago","Illinois","60612",{"type":31,"coordinates":81},[82,83],-87.65005,41.85003,{"lat":83,"lon":82},{"facility":86,"status":7,"city":87,"state":88,"zip":89,"country":28,"countryCode":29,"cosmosGeoPoint":90,"geoPoint":94,"contacts":7},"Johns Hopkins Univ School of Medicine","Baltimore","Maryland","21287",{"type":31,"coordinates":91},[92,93],-76.61219,39.29038,{"lat":93,"lon":92},{"facility":96,"status":7,"city":97,"state":98,"zip":99,"country":28,"countryCode":29,"cosmosGeoPoint":100,"geoPoint":104,"contacts":7},"Community Research Initiative","Brookline","Massachusetts","02445",{"type":31,"coordinates":101},[102,103],-71.12116,42.33176,{"lat":103,"lon":102},{"facility":106,"status":7,"city":107,"state":107,"zip":108,"country":28,"countryCode":29,"cosmosGeoPoint":109,"geoPoint":113,"contacts":7},"Community Research Initiative on AIDS","New York","10001",{"type":31,"coordinates":110},[111,112],-74.00597,40.71427,{"lat":112,"lon":111},{"facility":115,"status":7,"city":107,"state":107,"zip":116,"country":28,"countryCode":29,"cosmosGeoPoint":117,"geoPoint":119,"contacts":7},"Saint Vincent's AIDS Ctr","10011",{"type":31,"coordinates":118},[111,112],{"lat":112,"lon":111},{"facility":121,"status":7,"city":122,"state":123,"zip":124,"country":28,"countryCode":29,"cosmosGeoPoint":125,"geoPoint":129,"contacts":7},"Hershey Med Ctr \u002F Dept of Hematology","Hershey","Pennsylvania","17033",{"type":31,"coordinates":126},[127,128],-76.65025,40.28592,{"lat":128,"lon":127},{"facility":131,"status":7,"city":132,"state":133,"zip":134,"country":28,"countryCode":29,"cosmosGeoPoint":135,"geoPoint":139,"contacts":7},"Mem Hosp of Rhode Island","Pawtucket","Rhode Island","02860",{"type":31,"coordinates":136},[137,138],-71.38256,41.87871,{"lat":138,"lon":137},{"facility":141,"status":7,"city":142,"state":143,"zip":144,"country":28,"countryCode":29,"cosmosGeoPoint":145,"geoPoint":149,"contacts":7},"Univ of Texas Southwestern Med Ctr of Dallas","Dallas","Texas","75235",{"type":31,"coordinates":146},[147,148],-96.80667,32.78306,{"lat":148,"lon":147},{"facility":151,"status":7,"city":152,"state":153,"zip":154,"country":28,"countryCode":29,"cosmosGeoPoint":155,"geoPoint":159,"contacts":7},"Swedish Med Ctr","Seattle","Washington","98122",{"type":31,"coordinates":156},[157,158],-122.33207,47.60621,{"lat":158,"lon":157},{"facility":161,"status":7,"city":162,"state":7,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":7},"Hosp Regional de Ponce - Area Vieja","Ponce","00731","Puerto Rico","PR",{"type":31,"coordinates":167},[168,169],-66.62398,18.01031,{"lat":169,"lon":168},"100055286","phase-2-the-safety-and-effectiveness-of-adefovir-dipivoxil-plus-indinavir-combined-with-zidovudine-or-lamivudine-or-stavudine-in-hiv-infected-patients-who-have-not-taken-anti-hiv-drugs-100055286",false,"NCT00002379","The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs","A Phase II, Stratified, Randomized, Open-Label, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil and Indinavir in Combination With Zidovudine, Lamivudine, or Stavudine for the Treatment of Therapy Naive HIV-Infected Patients With CD4 Cell Counts >= 100 Cells\u002Fmm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies\u002FMl","Inclusion Criteria\n\nPatients must have:\n\n* Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture).\n* An HIV-1 RNA plasma titer \\>= 5000 copies\u002Fml within 14-21 days prior to the baseline visit.\n* CD4 cell count \\>= 100 cells\u002Fmm3 within 14-21 days prior to the baseline visit.\n* A minimum life expectancy of at least 1 year.\n* Signed, informed consent from parent or legal guardian for those patients \\\u003C 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with any of the following symptoms and conditions are excluded:\n\n* Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit.\n* Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.\n* Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study.\n* Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements.\n\nPatients with any of the following prior conditions are excluded:\n\n* A new AIDS-defining event diagnosed within 1 month prior to baseline.\n* Any patient who has previously been discontinued from zidovudine, lamivudine, and\u002For stavudine due to a drug-related toxicity.\n* Significant history of peripheral neuropathy.\n\n  1\\. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.\n* Saquinavir, ritonavir, nelfinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.\n\n  1\\. Prior use of adefovir dipivoxil.\n* Prior non-protease antiretroviral therapy (other than antiretroviral vaccines) for greater than 4 cumulative weeks.\n* Prior use of any antiretroviral protease inhibitor.\n* Immunizations within 30 days of baseline.\n* Antiretroviral vaccine therapy within 60 days of baseline.\n* Treatment in the 4 weeks prior to baseline, with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.\n* Any other investigational drug within 30 days prior to baseline.\n* Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.\n\nPatients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.","ALL","16 Years",{"count":181,"type":7},100,"INTERVENTIONAL",[184],"PHASE2","To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \\>= 100 cells\u002Fmm3 and an HIV-1 RNA baseline copy number \\>= 5000 copies\u002Fml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies\u002Fml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.",[187],"HIV Infections",[189,190,191,192,21,19,193,194,17,195,196,197,198,199],"HIV-1","Drug Therapy, Combination","Administration, Oral","Acquired Immunodeficiency Syndrome","HIV Protease Inhibitors","CD4 Lymphocyte Count","Indinavir","RNA, Viral","Adenine","Anti-HIV Agents","Viral Load","COMPLETED","2005-06-23",{"date":203,"type":204},"2005-06-24","ESTIMATED",{"name":206,"class":6},"Gilead Sciences",15]