Nctid:
NCT00001034
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003586", "term"=>"Cytomegalovirus Infections"}, {"id"=>"D000017726", "term"=>"Cytomegalovirus Retinitis"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000012173", "term"=>"Retinitis"}], "ancestors"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000012164", "term"=>"Retinal Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}, {"id"=>"D000015828", "term"=>"Eye Infections, Viral"}, {"id"=>"D000015817", "term"=>"Eye Infections"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "asFound"=>"Gastrointestinal Diseases", "relevance"=>"HIGH"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "asFound"=>"Gastrointestinal Diseases", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "asFound"=>"Cytomegalovirus (CMV)", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M16062", "name"=>"Stomach Diseases", "relevance"=>"LOW"}, {"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"=>"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 (CMV)", "relevance"=>"HIGH"}, {"id"=>"T1721", "name"=>"Cytomegalovirus Retinitis", "asFound"=>"Cytomegalovirus Retinitis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000015774", "term"=>"Ganciclovir"}, {"id"=>"C000092309", "term"=>"Ganciclovir triphosphate"}], "ancestors"=>[{"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M18331", "name"=>"Ganciclovir", "asFound"=>"Systemic therapy", "relevance"=>"HIGH"}, {"id"=>"M340476", "name"=>"Ganciclovir triphosphate", "asFound"=>"Systemic therapy", "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"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>850}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1995-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Retinitis", "Ganciclovir", "Cytomegalovirus Infections", "Administration, Oral", "Acquired Immunodeficiency Syndrome", "Gastrointestinal System"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections", "Gastrointestinal Diseases"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Brosgart C, Craig C, Louis TA, Hillman D, Costanzo L, Timpone J, Scott J, Nunley F, Stempien MJ. Design and demographics in a multicenter trial of cytomegalovirus (CMV) prophylaxis in advanced HIV disease. Int Conf AIDS. 1994 Aug 7-12;10(2):10 (abstract no 331B)"}, {"pmid"=>"9517989", "type"=>"BACKGROUND", "citation"=>"Brosgart CL, Louis TA, Hillman DW, Craig CP, Alston B, Fisher E, Abrams DI, Luskin-Hawk RL, Sampson JH, Ward DJ, Thompson MA, Torres RA. A randomized, placebo-controlled trial of the safety and efficacy of oral ganciclovir for prophylaxis of cytomegalovirus disease in HIV-infected individuals. Terry Beirn Community Programs for Clinical Research on AIDS. AIDS. 1998 Feb 12;12(3):269-77. doi: 10.1097/00002030-199803000-00004."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression.\n\nThe most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.", "detailedDescription"=>"The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.\n\nPatients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretroviral therapy.\n* Anti-PCP prophylaxis.\n* Maintenance or prophylaxis therapy for other opportunistic infections besides CMV.\n\nPatients must have:\n\n* Working diagnosis of HIV infection.\n* CD4 count \\<= 100 cells/mm3.\n* Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.\n* Reasonably good health.\n* Life expectancy of at least 6 months.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Acute life-threatening illness.\n* Active lymphoma.\n* Hypersensitivity to acyclovir.\n* Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Vidarabine.\n* Amantadine hydrochloride (Symmetrel).\n* CMV hyperimmune globulin/intravenous immune globulin.\n* Cytarabine.\n* Fiacitabine (FIAC) or fialuridine (FIAU).\n* Foscarnet.\n* Intravenous ganciclovir.\n* HPMPC.\n* Idoxuridine.\n* Intravenous acyclovir.\n* Oral acyclovir at \\> 1 g/day.\n* Other drugs with potential anti-CMV activity.\n\nPrior Medication:\n\nExcluded within 60 days prior to study entry:\n\n* Foscarnet.\n\nExcluded within 2 weeks prior to study entry:\n\n* Vidarabine.\n* Amantadine hydrochloride (Symmetrel).\n* CMV hyperimmune globulin/intravenous immune globulin.\n* Cytarabine.\n* Fiacitabine (FIAC) or fialuridine (FIAU).\n* Ganciclovir.\n* HPMPC.\n* Idoxuridine.\n* Intravenous acyclovir.\n* Oral acyclovir at \\> 1 g/day.\n* Other drugs with potential anti-CMV activity."}, "identificationModule"=>{"nctId"=>"NCT00001034", "briefTitle"=>"The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression", "orgStudyIdInfo"=>{"id"=>"CPCRA 023"}, "secondaryIdInfos"=>[{"id"=>"11573", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ganciclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Community Consortium of San Francisco", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80204", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver CPCRA / Denver Public Hlth", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"19899", "city"=>"Wilmington", "state"=>"Delaware", "country"=>"United States", "facility"=>"Wilmington Hosp / Med Ctr of Delaware", "geoPoint"=>{"lat"=>39.74595, "lon"=>-75.54659}}, {"zip"=>"20422", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Veterans Administration Med Ctr / Regional AIDS Program", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60657", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"AIDS Research Alliance - Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana Comm AIDS Rsch Prog / Tulane Univ Med", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Comprehensive AIDS Alliance of Detroit", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Henry Ford Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"07033", "city"=>"Kenilworth", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Schering - Plough Corp", "geoPoint"=>{"lat"=>40.67649, "lon"=>-74.2907}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"North Jersey Community Research Initiative", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10456", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Lebanon Hosp Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"11201", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"Addiction Research and Treatment Corp", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Clinical Directors Network of Region II", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem AIDS Treatment Group / Harlem Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"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"=>"23298", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"Richmond AIDS Consortium", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}], "overallOfficials"=>[{"name"=>"Brosgart C", "role"=>"STUDY_CHAIR"}, {"name"=>"Craig C", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
