Nctid:
NCT00002025
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D003586", "term"=>"Cytomegalovirus Infections"}, {"id"=>"D017726", "term"=>"Cytomegalovirus Retinitis"}, {"id"=>"D012173", "term"=>"Retinitis"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D012164", "term"=>"Retinal Diseases"}, {"id"=>"D005128", "term"=>"Eye Diseases"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D015828", "term"=>"Eye Infections, Viral"}, {"id"=>"D015817", "term"=>"Eye Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "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"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "asFound"=>"Cytomegalovirus Infections", "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"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M18371", "name"=>"Eye Infections", "relevance"=>"LOW"}, {"id"=>"M18382", "name"=>"Eye Infections, Viral", "relevance"=>"LOW"}, {"id"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "asFound"=>"Cytomegalovirus Infections", "relevance"=>"HIGH"}, {"id"=>"T1721", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}], "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"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015774", "term"=>"Ganciclovir"}, {"id"=>"C092309", "term"=>"Ganciclovir triphosphate"}], "ancestors"=>[{"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"=>"M18331", "name"=>"Ganciclovir", "asFound"=>"Therapeutic exercise", "relevance"=>"HIGH"}, {"id"=>"M340476", "name"=>"Ganciclovir triphosphate", "asFound"=>"Therapeutic exercise", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "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"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-09", "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"=>["Retinitis", "AIDS-Related Opportunistic Infections", "Immune Tolerance", "Injections, Intravenous", "Ganciclovir", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Cytomegalovirus Infections", "Cytomegalovirus Retinitis", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate the patient's clinical response."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"3 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.\n* Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.\n* Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.\n* Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.\n* Hypersensitivity to acyclovir or ganciclovir.\n* Receiving antimetabolite treatment that cannot be discontinued.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antimetabolites.\n* Alkylating agents.\n* Nucleoside analogs (topical ophthalmics are permitted).\n* Interferon.\n* Foscarnet.\n* Cytokines.\n\nPatients with the following are excluded:\n\n* Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.\n* Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.\n* Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.\n* Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.\n* Hypersensitivity to acyclovir or ganciclovir.\n* Receiving antimetabolite treatment that cannot be discontinued.\n\nPatients must qualify as follows:\n\n* Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study.\n* Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection.\n* Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease."}, "identificationModule"=>{"nctId"=>"NCT00002025", "briefTitle"=>"Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient", "orgStudyIdInfo"=>{"id"=>"029D"}, "secondaryIdInfos"=>[{"id"=>"ICM 1691"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ganciclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94303", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Roche Global Development - Palo Alto", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}}}}