[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100077970":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":7,"responsibleParty":7,"collaborators":7,"id":17,"slug":18,"hasResults":19,"nctId":20,"briefTitle":21,"officialTitle":22,"acronym":7,"eligibilityCriteria":23,"healthyVolunteers":19,"sex":24,"minAge":25,"maxAge":26,"enrollmentInfo":27,"targetDuration":7,"studyType":30,"phases":31,"briefSummary":33,"conditions":34,"keywords":37,"overallStatus":43,"whyStopped":7,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":7,"completionDateStruct":48,"leadSponsor":50,"locationsCount":7},{"fullName":5,"class":6},"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","epoetin alfa",[13],{"name":14,"affiliation":15,"role":16},"Ortho Biotech Products, L.P. Clinical Trial","Ortho Biotech, Inc.","STUDY_DIRECTOR","100077970","phase-2-a-study-to-evaluate-the-safety-and-efficacy-of-epoetin-alfa-versus-placebo-for-the-treatment-of-anemia-in-aids-acquired-immunodeficiency-syndrome-patients-with-anemia-caused-by-the-disease-and-by-zidovudine-azt-therapy-100077970",false,"NCT00270270","A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused by the Disease and by Zidovudine (AZT) Therapy","A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy","Inclusion Criteria: - Patients with a confirmed diagnosis of AIDS, with a hematocrit \\\u003C=30% - preferably dependent on transfusions - having a history of at least a 15% decrease in hematocrit since the beginning of AZT therapy, or have become dependent on transfusions - who are clinically stable for at least 1 month before study entry - females must be at least 1 year post-menopausal, surgically sterile, or practicing an effective method of birth control, and have a negative pregnancy test before study entry.\n\nExclusion Criteria: - Patients with a history of any primary blood disease - having any clinically significant disease or malfunction of the lungs, heart, hormones, neurological, gastrointestinal, reproductive or urinary systems, which is not caused by the AIDS infection - having uncontrolled high blood pressure - having anemia caused by conditions other than AIDS (for example, vitamin deficiency or bleeding from the gastrointestinal tract) - having a serum ferritin value \\\u003C30 ng\u002FmL or an iron\u002Ftotal iron-binding capacity (Fe\u002FTIBC) ratio less than 15%.","ALL","18 Years","75 Years",{"count":28,"type":29},63,"ACTUAL","INTERVENTIONAL",[32],"PHASE2","The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus placebo in AIDS patients for the treatment of anemia that is a result of the disease or a result of zidovudine (AZT) treatment for AIDS. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.",[35,36],"Acquired Immunodeficiency Syndrome","Anemia",[38,36,39,11,40,41,42],"erythropoietin","Quality of Life","HIV","Zidovudine","AIDS","COMPLETED","2011-05-17",{"date":46,"type":47},"2011-05-18","ESTIMATED",{"date":49,"type":29},"1989-07",{"name":5,"class":6}]