Nctid:
NCT00002008
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000095542", "term"=>"Cytopenia"}, {"id"=>"D007970", "term"=>"Leukopenia"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D007960", "term"=>"Leukocyte Disorders"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M17522", "name"=>"Virus Diseases", "asFound"=>"Virus Infection", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M3170", "name"=>"Cytopenia", "asFound"=>"Cytopenia", "relevance"=>"HIGH"}, {"id"=>"M10973", "name"=>"Leukopenia", "asFound"=>"Leukopenia", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M10963", "name"=>"Leukocyte Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C081222", "term"=>"Sargramostim"}], "ancestors"=>[{"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M257633", "name"=>"Molgramostim", "relevance"=>"LOW"}, {"id"=>"M219218", "name"=>"Sargramostim", "asFound"=>"Individualized", "relevance"=>"HIGH"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-01", "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"=>["Leukopenia", "Drug Evaluation", "Granulocyte-Macrophage Colony-Stimulating Factor"], "conditions"=>["HIV Infections", "Cytopenias"]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Serum antibody to HIV with or without evidence of HIV.\n* Antigenemia.\n* Anticipated survival of at least 6 months.\n* Allowed:\n* Kaposi's sarcoma.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Malignancy other than Kaposi's sarcoma.\n* Excessive diarrhea (more than 5 liquid or non-liquid stools per day).\n* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.\n* Primary hematologic or infectious disorders unrelated to AIDS virus infection.\n* Dementia or altered mental status that would prohibit the giving and understanding of informed consent.\n\nPatients with the following are excluded:\n\n* History of malignancy other than Kaposi's sarcoma.\n* Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.\n\nPrior Medication:\n\nExcluded within 3 weeks of study entry:\n\n* Marrow suppressive medication.\n* Excluded within 4 weeks of study entry:\n* Any investigational drug.\n\nPrior Treatment:\n\nExcluded within 4 weeks of study entry:\n\n* Systemic cytotoxic chemotherapy.\n* Irradiation.\n\nRisk Behavior:\n\nExcluded within 3 months of study entry:\n\n* Regular, excessive users of alcohol, hallucinogens, or agents which are addicting."}, "identificationModule"=>{"nctId"=>"NCT00002008", "briefTitle"=>"An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia", "orgStudyIdInfo"=>{"id"=>"067D"}, "secondaryIdInfos"=>[{"id"=>"106"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Sargramostim", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess - West Campus", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sandoz", "class"=>"INDUSTRY"}}}}
