Nctid:
NCT00002273
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003092", "term"=>"Colitis"}], "ancestors"=>[{"id"=>"D005759", "term"=>"Gastroenteritis"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D003108", "term"=>"Colonic Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}], "browseLeaves"=>[{"id"=>"M6320", "name"=>"Colitis", "asFound"=>"Colitis", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M8875", "name"=>"Gastroenteritis", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"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"=>"Epidermal Growth Factor", "relevance"=>"HIGH"}, {"id"=>"M340476", "name"=>"Ganciclovir triphosphate", "asFound"=>"Epidermal Growth Factor", "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"=>"DOUBLE"}, "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"=>["AIDS-Related Opportunistic Infections", "Ganciclovir", "Cytomegalovirus Infections", "Colitis", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Colitis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8380610", "type"=>"BACKGROUND", "citation"=>"Dieterich DT, Kotler DP, Busch DF, Crumpacker C, Du Mond C, Dearmand B, Buhles W. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis. 1993 Feb;167(2):278-82. doi: 10.1093/infdis/167.2.278."}]}, "descriptionModule"=>{"briefSummary"=>"To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters. To determine acceptability and the safety profile of a 2-week course of intravenous (IV) DHPG therapy."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* An underlying diagnosis of AIDS by CDC surveillance definition (group IV, category c-1 or subgroup D only).\n* Colitis manifested clinically by diarrhea.\n* Colon biopsy demonstrating a typical histologic picture of cytomegalovirus (CMV) disease.\n* Cultures for CMV from blood and urine should be obtained within 1 week of study entry but need not be positive prior to entry. (A positive culture is needed for final inclusion in AN.)\n\nPrior Medication:\n\nAllowed:\n\n* Topical acyclovir.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* History of chronic or acute liver disease.\n* History of significant mental illness.\n* Life expectancy \\< 1 month.\n* Presence of any cause of colitis other than cytomegalovirus (CMV). (The following tests must be negative:\n* Stool culture for enteric bacterial pathogens, stool exam for ova and parasites, stool exam for cryptosporidia, stool exam for AFB.) Colitis that is so severe that it would be against the patient's best interest to be treated with placebo for 2 weeks prior to being eligible to receive ganciclovir (DHPG) on a \"compassionate\" use basis. Patients with a colitis of this severity should be treated with DHPG on \"compassionate\" use basis.\n* Presence of clinically significant extra-colonic active CMV disease of retina or visceral organs (which could progress during the no-treatment period).\n* Presence of significant renal disease resulting in any decrement of creatinine clearance from normal.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any other investigational drug, whether or not as part of a formal clinical study.\n\nPatients with the following are excluded:\n\n* History of chronic or acute liver disease.\n* History of significant mental illness.\n* Life expectancy \\< 1 month.\n* Presence of any cause of colitis other than cytomegalovirus (CMV). (The following tests must be negative:\n* Stool culture for enteric bacterial pathogens, stool exam for ova and parasites, stool exam for cryptosporidia, stool exam for AFB.) Colitis that is so severe that it would be against the patient's best interest to be treated with placebo for 2 weeks prior to being eligible to receive ganciclovir (DHPG) on a \"compassionate\" use basis. Patients with a colitis of this severity should be treated with DHPG on \"compassionate\" use basis.\n* Presence of clinically significant extra-colonic active CMV disease of retina or visceral organs (which could progress during the no-treatment period).\n* Presence of significant renal disease resulting in any decrement of creatinine clearance from normal.\n\nPrior Medication:\n\nExcluded within 2 days of study entry:\n\n* Nucleoside analogs.\n* Excluded within 1 week of study entry:\n* Antimetabolites or interferon."}, "identificationModule"=>{"nctId"=>"NCT00002273", "briefTitle"=>"A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome", "orgStudyIdInfo"=>{"id"=>"029C"}, "secondaryIdInfos"=>[{"id"=>"ICM 1288"}]}, "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"}}}}
