Nctid:
NCT00002296
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008206", "term"=>"Lymphatic Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M994", "name"=>"Lymphadenopathy", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "asFound"=>"Lymphatic Diseases", "relevance"=>"HIGH"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D007542", "term"=>"Inosine Pranobex"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M10574", "name"=>"Inosine Pranobex", "asFound"=>"Migraine Prophylaxis", "relevance"=>"HIGH"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-06", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["T-Lymphocytes", "Immune Tolerance", "Inosine Pranobex", "Killer Cells", "T-Lymphocytes, Helper-Inducer", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"], "conditions"=>["Lymphatic Disease", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:\n\n* Increase in natural killer (NK) cell activity.\n* Increase in total T-cells (OKT-11).\n* Increases in absolute number and percentage of T-helper cells (OKT-4)."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.\n* Lymphoid malignancy.\n* Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.\n* Heart disease (especially if receiving cardiac glycosides).\n* Hemophilia.\n\nPatients with the following are excluded:\n\n* Kaposi's sarcoma or overt opportunistic infections as follows:\n* Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.\n* Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).\n* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.\n* Critical illness.\n* Condition requiring hospitalization.\n* Women of childbearing age are excluded.\n* Hemophilia.\n\nPrior Medication:\n\nExcluded:\n\n* Steroids.\n* Cytotoxic immunosuppressive agents.\n* Antiviral medicine.\n\nPrior Treatment:\n\nExcluded:\n\n* Radiotherapy.\n\nPatients who have unexplained immunodepression and are at risk of developing AIDS.\n\n* Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).\n\nIV drug abuse."}, "identificationModule"=>{"nctId"=>"NCT00002296", "briefTitle"=>"The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy", "orgStudyIdInfo"=>{"id"=>"008C"}, "secondaryIdInfos"=>[{"id"=>"ISO-106-USA"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Inosine pranobex", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92656", "city"=>"Laguna Hills", "state"=>"California", "country"=>"United States", "facility"=>"Newport Pharmaceuticals International Inc", "geoPoint"=>{"lat"=>33.61252, "lon"=>-117.71283}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Newport Pharmaceuticals International", "class"=>"INDUSTRY"}}}}
