Nctid:
NCT00002039
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "relevance"=>"LOW"}, {"id"=>"T1721", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"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"=>"D017245", "term"=>"Foscarnet"}, {"id"=>"D010746", "term"=>"Phosphonoacetic Acid"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "relevance"=>"LOW"}, {"id"=>"M19543", "name"=>"Foscarnet", "asFound"=>"Texas", "relevance"=>"HIGH"}, {"id"=>"M13647", "name"=>"Phosphonoacetic Acid", "asFound"=>"Behavioral modification", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "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"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1991-03", "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", "Drug Therapy, Combination", "Foscarnet", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome", "Antiviral Agents", "Zidovudine"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Ussery FM, Karol C, Conklin R, Gathe J, Stool E, Redding K. Preliminary results from an on-going prospective evaluation of foscarnet in the treatment of AIDS-associated cytomegalovirus retinitis. Int Conf AIDS. 1989 Jun 4-9;5:551 (abstract no MCP60)"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).\n* Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic and/or hypertensive retinopathy.\n* Known allergy to foscarnet.\n* Recurrent episode of cytomegalovirus (CMV) retinitis.\n\nConcurrent Medication:\n\nExcluded:\n\n* Nephrotoxic drugs.\n\nPatients with the following are excluded:\n\n* Recurrent episode of cytomegalovirus (CMV) retinitis.\n* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).\n* Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.\n* Known allergy to foscarnet.\n\nPrior Medication:\n\nExcluded:\n\n* Ganciclovir for cytomegalovirus (CMV) retinitis.\n* Foscarnet for CMV retinitis.\n\nPatients with AIDS as defined by the CDC with manifest first episode cytomegalovirus (CMV) retinitis, as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.\n\n* Patients must be able to give informed consent."}, "identificationModule"=>{"nctId"=>"NCT00002039", "briefTitle"=>"An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients", "orgStudyIdInfo"=>{"id"=>"020A"}, "secondaryIdInfos"=>[{"id"=>"88-FOS-01"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Foscarnet sodium", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77004", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Foscarnet Research Program / Park Plaza Hosp", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Astra USA", "class"=>"INDUSTRY"}}}}
