Nctid:
NCT00002330
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M19939", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}, {"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"=>"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"=>"Anastrozole", "relevance"=>"HIGH"}, {"id"=>"M340476", "name"=>"Ganciclovir triphosphate", "asFound"=>"Anastrozole", "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"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>280}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-04", "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", "Ganciclovir", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)"}]}, "descriptionModule"=>{"briefSummary"=>"To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.", "detailedDescription"=>"Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Topical and ophthalmic nucleoside analogues.\n\nPatients must have:\n\n* HIV positive.\n* No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.\n* Currently stable retinitis.\n\nPrior Medication:\n\nAllowed:\n\n* Foscarnet prior to the 4 weeks of intravenous induction therapy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Persistent or clinically significant diarrhea, nausea, or abdominal pain.\n* Severe odynophagia.\n* Other gastrointestinal (GI) symptoms or uncontrolled GI disease.\n* Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).\n* Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.\n* Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.\n\nConcurrent Medication:\n\nExcluded:\n\n* Acyclovir sodium (Zovirax) by any route other than topical.\n* Valacyclovir.\n* Brovavir.\n* Vidarabine.\n* Amantadine hydrochloride.\n* Cytarabine.\n* Idoxuridine.\n* Ribavirin.\n* Interferon.\n* Foscarnet (non-nucleoside pyrophosphate analogue).\n* CMV hyperimmune globulin.\n* Soluble CD4.\n* Trichosanthin (Compound Q).\n* Imipenem-cilastatin.\n* Isoprinosine.\n* Levamisole.\n* Other investigational drugs.\n\nPatients with the following prior condition are excluded:\n\nHistory of hypersensitivity to acyclovir or ganciclovir.\n\nPrior Medication:\n\nExcluded:\n\n* More than three induction regimens with intravenous anti-CMV therapy.\n* Any prior oral ganciclovir."}, "identificationModule"=>{"nctId"=>"NCT00002330", "briefTitle"=>"A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS", "orgStudyIdInfo"=>{"id"=>"059F"}, "secondaryIdInfos"=>[{"id"=>"GANs2226"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ganciclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham / AIDS Outpatient Clinic", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"85006", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"McDowell Clinic", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"85013", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"Dr Ken Fisher", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"85724", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Univ of Arizona / Health Science Ctr", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"94705", "city"=>"Berkeley", "state"=>"California", "country"=>"United States", "facility"=>"East Bay AIDS Ctr", "geoPoint"=>{"lat"=>37.87159, "lon"=>-122.27275}}, {"zip"=>"900951793", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"AIDS Clinical Research Ctr / UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Med Ctr / Pediatrics", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94114", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Davies Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Mount Zion Med Ctr / UCSF", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94121", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33146", "city"=>"Coral Gables", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative", "geoPoint"=>{"lat"=>25.72149, "lon"=>-80.26838}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Margo Heath - Chiozzi", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ of Maryland School of Medicine", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"63108", "city"=>"St. Louis", "state"=>"Missouri", "country"=>"United 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{"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York Hosp - Cornell Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina School of Medicine", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"282072198", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Nalle Clinic", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"432101228", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ Hosp", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"74114", "city"=>"Tulsa", "state"=>"Oklahoma", "country"=>"United States", "facility"=>"Associates Med and Mental Health", "geoPoint"=>{"lat"=>36.15398, "lon"=>-95.99277}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Buckley Braffman Stern Med Associates", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"78705", "city"=>"Austin", "state"=>"Texas", "country"=>"United States", "facility"=>"Austin Infectious Disease Consultants", "geoPoint"=>{"lat"=>30.26715, "lon"=>-97.74306}}, {"zip"=>"75219", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"N Texas Ctr for AIDS & Clin Rsch", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"79905", "city"=>"El Paso", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Tech Health Sciences Ctr", 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