Nctid:
NCT00002187
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D017726", "term"=>"Cytomegalovirus Retinitis"}, {"id"=>"D012173", "term"=>"Retinitis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"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"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "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"=>"M6791", "name"=>"Cytomegalovirus Infections", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"T1721", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}, {"id"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "relevance"=>"LOW"}], "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"=>"C091346", "term"=>"Fomivirsen"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M263157", "name"=>"Fomivirsen", "asFound"=>"A3-A", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "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", "interventionModel"=>"PARALLEL"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-12", "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", "Antiviral Agents", "Drug Administration Schedule", "Cytomegalovirus Retinitis", "fomivirsen", "Vitreous Body"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"AIDS Alert. New CMV drug won't replace other therapies. 1998 Nov;13(11):124-6."}, {"pmid"=>"11365956", "type"=>"BACKGROUND", "citation"=>"Roehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis", "detailedDescription"=>"This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Oral ganciclovir.\n* Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.\n\nPatients must have:\n\n* Documented AIDS.\n* Clinical diagnosis of advanced CMV retinitis in 1 or both eyes.\n* \\>= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.\n* \\> 25% retinal involvement with CMV retinitis.\n* Baseline CMV retinitis lesions which have leading edges \\> 1000 micrograms from the macula or optic disk.\n\nPrior Medication:\n\nRequired:\n\n* \\>= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.\n\nAllowed:\n\n* All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* External ocular infection in the eye to be treated.\n* Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated.\n* Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated.\n* Retinal detachment in the eye to be treated.\n* Ganciclovir implant in the eye to be treated.\n* Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922.\n* Silicone oil in the eye to be treated.\n* Pseudoretinitis pigmentosa.\n* Syphilis.\n\nPatients with the following prior conditions are excluded:\n\n* History of surgery to correct retinal detachment in the eye to be treated.\n* History of syphilis.\n\n 1. Systemic anti-CMV therapies other than oral ganciclovir.\n* Mellaril, Stelazine, chlorpromazine and clofazimine.\n* Combination use of ethambutol and fluconazole.\n* Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated.\n* Ganciclovir implant delivery device in the eye to be treated.\n* Ganciclovir other than oral.\n* Foscarnet."}, "identificationModule"=>{"nctId"=>"NCT00002187", "briefTitle"=>"A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis", "orgStudyIdInfo"=>{"id"=>"251D"}, "secondaryIdInfos"=>[{"id"=>"ISIS 2922-CS9"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Fomivirsen sodium", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90017", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Retina - Vitreous Associates Med Group", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"911052536", "city"=>"Pasadena", "state"=>"California", "country"=>"United States", "facility"=>"Community Eye Med Group", "geoPoint"=>{"lat"=>34.14778, "lon"=>-118.14452}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Univ of California San Francisco / SF Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Dr Jacob Lalezari", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20006", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Dr Alan Palestine", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33060", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Dr Julio Perez", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"30327", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Georgia Retina", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60610", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Ctr for Clinical Research", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Illinois", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Med Ctr", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10028", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Vitreo - Retinal Consultants", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"28204", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Charlotte Eye Ear Nose & Throat Association", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"191021192", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Hahnemann Univ Hosp", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Novum Inc", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ionis Pharmaceuticals, Inc.", "class"=>"INDUSTRY"}}}}