Nctid:
NCT00002263
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009503", "term"=>"Neutropenia"}, {"id"=>"D000095542", "term"=>"Cytopenia"}], "ancestors"=>[{"id"=>"D000380", "term"=>"Agranulocytosis"}, {"id"=>"D007970", "term"=>"Leukopenia"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D007960", "term"=>"Leukocyte Disorders"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M12443", "name"=>"Neutropenia", "asFound"=>"Neutropenia", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3170", "name"=>"Cytopenia", "asFound"=>"Cytopenia", "relevance"=>"HIGH"}, {"id"=>"M3730", "name"=>"Agranulocytosis", "relevance"=>"LOW"}, {"id"=>"M10973", "name"=>"Leukopenia", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M10963", "name"=>"Leukocyte Disorders", "relevance"=>"LOW"}, {"id"=>"T2606", "name"=>"Granulocytopenia", "asFound"=>"Neutropenia", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"C081222", "term"=>"Sargramostim"}], "ancestors"=>[{"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M257633", "name"=>"Molgramostim", "relevance"=>"LOW"}, {"id"=>"M219218", "name"=>"Sargramostim", "asFound"=>"Final", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Discretion", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1990-01", "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"=>["Pilot Projects", "Neutropenia", "Granulocyte-Macrophage Colony-Stimulating Factor", "Acquired Immunodeficiency Syndrome", "Zidovudine"], "conditions"=>["HIV Infections", "Cytopenias"]}, "descriptionModule"=>{"briefSummary"=>"To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 years", "minimumAge"=>"6 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT) on NIAID 86-C-175.\n\nPatients must have:\n\n* Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.\n* Granulocytopenia (\\< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.\n* Life expectancy \\> 3 months.\n* Functioning indwelling central venous access device in place.\n\nPrior Medication:\n\nAllowed within 48 hours of study entry:\n\n* Prophylactic antibiotics.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Critically ill or clinically unstable.\n* Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.\n* Ongoing IV alimentation.\n* Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.\n* Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.\n* Malignancy likely to require systemic treatment during study.\n\nPatients with the following are excluded:\n\n* Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.\n* Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.\n\nPrior Medication:\n\nExcluded within 48 hours of study entry:\n\n* Antibiotics.\n* Excluded within 30 days of study entry:\n* Antiretroviral agents other than zidovudine (AZT).\n* Acyclovir.\n* Ganciclovir.\n* Any investigational drug.\n* Immunomodulating drugs.\n* Cytolytic chemotherapeutic agents.\n* Corticosteroids.\n* Immunoglobulin preparations.\n* Excluded within 4 months of study entry:\n* Suramin.\n\nPrior Treatment:\n\nExcluded within 6 months of study entry:\n\n* Bone marrow transplantation.\n* Excluded within 4 weeks of study entry:\n* Lymphocyte transfusions.\n* Radiation therapy."}, "identificationModule"=>{"nctId"=>"NCT00002263", "briefTitle"=>"A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine", "orgStudyIdInfo"=>{"id"=>"067B"}, "secondaryIdInfos"=>[{"id"=>"206"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Sargramostim", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"Natl Cancer Institute / HIV / AIDS Malignancy Branch", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sandoz", "class"=>"INDUSTRY"}}}}