Nctid:
NCT00002070
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D017726", "term"=>"Cytomegalovirus Retinitis"}, {"id"=>"D012173", "term"=>"Retinitis"}], "ancestors"=>[{"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D012164", "term"=>"Retinal Diseases"}, {"id"=>"D005128", "term"=>"Eye Diseases"}, {"id"=>"D015828", "term"=>"Eye Infections, Viral"}, {"id"=>"D015817", "term"=>"Eye Infections"}, {"id"=>"D003586", "term"=>"Cytomegalovirus Infections"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12443", "name"=>"Neutropenia", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19939", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M18371", "name"=>"Eye Infections", "relevance"=>"LOW"}, {"id"=>"M18382", "name"=>"Eye Infections, Viral", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"T2606", "name"=>"Granulocytopenia", "relevance"=>"LOW"}, {"id"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "relevance"=>"LOW"}, {"id"=>"T1721", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015774", "term"=>"Ganciclovir"}, {"id"=>"C092309", "term"=>"Ganciclovir triphosphate"}, {"id"=>"C081222", "term"=>"Sargramostim"}], "ancestors"=>[{"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M257633", "name"=>"Molgramostim", "relevance"=>"LOW"}, {"id"=>"M219218", "name"=>"Sargramostim", "asFound"=>"1-2", "relevance"=>"HIGH"}, {"id"=>"M18331", "name"=>"Ganciclovir", "asFound"=>"Ciprofloxacin", "relevance"=>"HIGH"}, {"id"=>"M340476", "name"=>"Ganciclovir triphosphate", "asFound"=>"Ciprofloxacin", "relevance"=>"HIGH"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1991-05", "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"=>["Recombinant Proteins", "Retinitis", "AIDS-Related Opportunistic Infections", "Neutropenia", "Ganciclovir", "Drug Therapy, Combination", "Granulocyte-Macrophage Colony-Stimulating Factor", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatient must have the following:\n\n* AIDS as defined by CDC criteria.\n* Retinitis as diagnosed by the study ophthalmologist.\n* Performance status 0, 1, or 2.\n* Ability to give informed consent and suitability of intravenous access for scheduled blood tests.\n* Patient may have Kaposi's sarcoma or basal skin cancer.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Active acute infection requiring treatment.\n* Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.\n* Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.\n\nPatients with the following are excluded:\n\n* Active acute infection requiring treatment.\n* Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.\n* Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.\n\nPrior Medication:\n\nExcluded:\n\n* Granulocyte macrophage colony-stimulating factor (GM-CSF).\n* Colony stimulating factor.\n* Interleukin 3.\n* Excluded within 7 days of study entry:\n* Zidovudine (AZT).\n* Trimethoprim / sulfamethoxazole (TMP / SMX).\n* Pyrimethamine.\n* Excluded within 30 days of study entry:\n* Biologic response modifiers.\n* Cytotoxic agents.\n* Investigational agents.\n\nPrior Treatment:\n\nExcluded:\n\n* Radiation therapy.\n\nRequired within 1 week of study entry:\n\n* One or more doses of ganciclovir."}, "identificationModule"=>{"nctId"=>"NCT00002070", "briefTitle"=>"Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis", "orgStudyIdInfo"=>{"id"=>"005A"}, "secondaryIdInfos"=>[{"id"=>"C88-059"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Sargramostim", "type"=>"DRUG"}, {"name"=>"Ganciclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC School of Medicine / Norris Cancer Hosp", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94118", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp of San Francisco", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94118", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Pacific Presbyterian", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"91403", "city"=>"Sherman Oaks", "state"=>"California", "country"=>"United States", "facility"=>"Gottlieb Med Group", "geoPoint"=>{"lat"=>34.15112, "lon"=>-118.44925}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cabrini Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Dr Douglas Dieterich", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10025", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Luke's - Roosevelt Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Methodist Hosp", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"22203", "city"=>"Annandale", "state"=>"Virginia", "country"=>"United States", "facility"=>"Infectious Disease Physicians Inc", "geoPoint"=>{"lat"=>38.83039, "lon"=>-77.19637}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Schering-Plough", "class"=>"INDUSTRY"}}}}
