Nctid:
NCT00002297
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008206", "term"=>"Lymphatic Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"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"=>"Kidney Dysfunction", "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"=>["Inosine Pranobex", "AIDS-Related Complex"], "conditions"=>["Lymphatic Disease", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:\n\nSigns and symptoms:\n\n* Lymphadenopathy.\n* Fever.\n* Weight loss.\n* Occurrence of opportunistic infections.\n\nCell-mediated immune system parameters:\n\n* T-helper cell (OKT4) numbers and proportions.\n* T-suppressor cell (OKT8) numbers and proportions.\n* Natural killer (NK) cell activity.\n* Lymphocyte blastogenic response to phytohemagglutinin (PHA).\n* Lymphocyte blastogenic response to pokeweed mitogen (PWM).\n* Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.\n* Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.\n\nSafety parameters:\n\n* Blood chemistry including serum uric acid (PurposeA-12).\n* Complete blood count (CBC).\n* Platelet count."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.\n\nConcurrent Medication:\n\nExcluded:\n\n* Systemic corticosteroids.\n* Cytotoxic immunosuppressive agents.\n* Radiotherapy.\n\nCritically ill patients or those with CDC-defined AIDS are excluded.\n\nPrior Medication:\n\nExcluded within 1 month of study entry:\n\n* Immunotherapy.\n\nPatients with persistent generalized lymphadenopathy (PGL)."}, "identificationModule"=>{"nctId"=>"NCT00002297", "briefTitle"=>"A Study of Isoprinosine in Patients With Lymph Node Disease", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy", "orgStudyIdInfo"=>{"id"=>"008A"}, "secondaryIdInfos"=>[{"id"=>"ISO-103-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"}}}}
