Nctid:
NCT00000143
Payload:
{"FullStudy"=>{"Rank"=>499167, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000017726", "ConditionMeshTerm"=>"Cytomegalovirus Retinitis"}, {"ConditionMeshId"=>"D000012173", "ConditionMeshTerm"=>"Retinitis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000012164", "ConditionAncestorTerm"=>"Retinal Diseases"}, {"ConditionAncestorId"=>"D000005128", "ConditionAncestorTerm"=>"Eye Diseases"}, {"ConditionAncestorId"=>"D000015828", "ConditionAncestorTerm"=>"Eye Infections, Viral"}, {"ConditionAncestorId"=>"D000015817", "ConditionAncestorTerm"=>"Eye Infections"}, {"ConditionAncestorId"=>"D000003586", "ConditionAncestorTerm"=>"Cytomegalovirus Infections"}, {"ConditionAncestorId"=>"D000006566", "ConditionAncestorTerm"=>"Herpesviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15008", "ConditionBrowseLeafName"=>"Retinitis", "ConditionBrowseLeafAsFound"=>"Retinitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M19939", "ConditionBrowseLeafName"=>"Cytomegalovirus Retinitis", "ConditionBrowseLeafAsFound"=>"Cytomegalovirus Retinitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14999", "ConditionBrowseLeafName"=>"Retinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8271", "ConditionBrowseLeafName"=>"Eye Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18371", "ConditionBrowseLeafName"=>"Eye Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18382", "ConditionBrowseLeafName"=>"Eye Infections, Viral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6791", "ConditionBrowseLeafName"=>"Cytomegalovirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9643", "ConditionBrowseLeafName"=>"Herpesviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7442", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1721", "ConditionBrowseLeafName"=>"Cytomegalovirus Retinitis", "ConditionBrowseLeafAsFound"=>"Cytomegalovirus Retinitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T1720", "ConditionBrowseLeafName"=>"Cytomegalic Inclusion Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Eye Diseases", "ConditionBrowseBranchAbbrev"=>"BC11"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000015774", "InterventionMeshTerm"=>"Ganciclovir"}, {"InterventionMeshId"=>"C000092309", "InterventionMeshTerm"=>"Ganciclovir triphosphate"}, {"InterventionMeshId"=>"D000077404", "InterventionMeshTerm"=>"Cidofovir"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M18331", "InterventionBrowseLeafName"=>"Ganciclovir", "InterventionBrowseLeafAsFound"=>"Warning", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M340476", "InterventionBrowseLeafName"=>"Ganciclovir triphosphate", "InterventionBrowseLeafAsFound"=>"Warning", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1785", "InterventionBrowseLeafName"=>"Cidofovir", "InterventionBrowseLeafAsFound"=>"Bare metal stent", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ResultsSection"=>{"MoreInfoModule"=>{"PointOfContact"=>{"PointOfContactEMail"=>"cmeinert@jhsph.edu", "PointOfContactPhone"=>"410-955-8198", "PointOfContactTitle"=>"Curtis Meinert, PhD", "PointOfContactOrganization"=>"Johns Hopkins School of Public Health"}, "CertainAgreement"=>{"AgreementPISponsorEmployee"=>"No", "AgreementRestrictiveAgreement"=>"No"}}, "AdverseEventsModule"=>{"EventGroupList"=>{"EventGroup"=>[{"EventGroupId"=>"EG000", "EventGroupTitle"=>"Ganciclovir Implant and Oral Ganciclovir", "EventGroupDescription"=>"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily\n\nGanciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily", "EventGroupOtherNumAtRisk"=>"31", "EventGroupOtherNumAffected"=>"0", "EventGroupSeriousNumAtRisk"=>"31", "EventGroupSeriousNumAffected"=>"0"}, {"EventGroupId"=>"EG001", "EventGroupTitle"=>"Cidofovir IV (Intravenous)", "EventGroupDescription"=>"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week\n\nCidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week", "EventGroupOtherNumAtRisk"=>"30", "EventGroupOtherNumAffected"=>"0", "EventGroupSeriousNumAtRisk"=>"30", "EventGroupSeriousNumAffected"=>"0"}]}, "EventsTimeFrame"=>"3 years", "EventsFrequencyThreshold"=>"0"}, "OutcomeMeasuresModule"=>{"OutcomeMeasureList"=>{"OutcomeMeasure"=>[{"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"31", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"30", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"31", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"30", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Ganciclovir Implant and Oral Ganciclovir", "OutcomeGroupDescription"=>"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily\n\nGanciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Cidofovir IV (Intravenous)", "OutcomeGroupDescription"=>"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week\n\nCidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"}]}, "OutcomeMeasureType"=>"Primary", "OutcomeMeasureTitle"=>"Survival", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"3 years", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted"}]}}, "ParticipantFlowModule"=>{"FlowGroupList"=>{"FlowGroup"=>[{"FlowGroupId"=>"FG000", "FlowGroupTitle"=>"Ganciclovir Implant and Oral Ganciclovir", "FlowGroupDescription"=>"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily\n\nGanciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"}, {"FlowGroupId"=>"FG001", "FlowGroupTitle"=>"Cidofovir IV (Intravenous)", "FlowGroupDescription"=>"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week\n\nCidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"}]}, "FlowPeriodList"=>{"FlowPeriod"=>[{"FlowPeriodTitle"=>"Overall Study", "FlowMilestoneList"=>{"FlowMilestone"=>[{"FlowMilestoneType"=>"STARTED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"31"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"30"}]}}, {"FlowMilestoneType"=>"COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"31"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"30"}]}}, {"FlowMilestoneType"=>"NOT COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"0"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"0"}]}}]}}]}, "FlowRecruitmentDetails"=>"June 1997"}, "BaselineCharacteristicsModule"=>{"BaselineDenomList"=>{"BaselineDenom"=>[{"BaselineDenomUnits"=>"Participants", "BaselineDenomCountList"=>{"BaselineDenomCount"=>[{"BaselineDenomCountValue"=>"31", "BaselineDenomCountGroupId"=>"BG000"}, {"BaselineDenomCountValue"=>"30", "BaselineDenomCountGroupId"=>"BG001"}, {"BaselineDenomCountValue"=>"61", "BaselineDenomCountGroupId"=>"BG002"}]}}]}, "BaselineGroupList"=>{"BaselineGroup"=>[{"BaselineGroupId"=>"BG000", "BaselineGroupTitle"=>"Ganciclovir Implant and Oral Ganciclovir", "BaselineGroupDescription"=>"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily\n\nGanciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"}, {"BaselineGroupId"=>"BG001", "BaselineGroupTitle"=>"Cidofovir IV (Intravenous)", "BaselineGroupDescription"=>"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week\n\nCidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"}, {"BaselineGroupId"=>"BG002", "BaselineGroupTitle"=>"Total", "BaselineGroupDescription"=>"Total of all reporting groups"}]}, "BaselineMeasureList"=>{"BaselineMeasure"=>[{"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"<=18 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Between 18 and 65 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"31", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"30", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"61", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>">=65 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Age, Categorical", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Female", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"7", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"5", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"12", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Male", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"24", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"25", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"49", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Sex: Female, Male", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"United States", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"31", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"30", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"61", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Region of Enrollment", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"61"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"July 2015", "CompletionDateStruct"=>{"CompletionDate"=>"June 2000", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"February 18, 2016", "StudyFirstSubmitDate"=>"September 23, 1999", "ResultsFirstSubmitDate"=>"July 1, 2015", "StudyFirstSubmitQCDate"=>"September 23, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 14, 2016", "LastUpdatePostDateType"=>"Estimate"}, "ResultsFirstSubmitQCDate"=>"February 18, 2016", "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 24, 1999", "StudyFirstPostDateType"=>"Estimate"}, "ResultsFirstPostDateStruct"=>{"ResultsFirstPostDate"=>"March 14, 2016", "ResultsFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2000", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Survival", "PrimaryOutcomeTimeFrame"=>"3 years"}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cytomegalovirus Retinitis", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11292409", "ReferenceType"=>"background", "ReferenceCitation"=>"Studies of Ocular Complications of AIDS Research Group. The AIDS Clinical Trials Group.. The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Am J Ophthalmol. 2001 Apr;131(4):457-67. doi: 10.1016/s0002-9394(01)00840-6."}, {"ReferencePMID"=>"15076943", "ReferenceType"=>"background", "ReferenceCitation"=>"Dunn JP, Van Natta M, Foster G, Kuppermann BD, Martin DF, Zong A, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Complications of ganciclovir implant surgery in patients with cytomegalovirus retinitis: the Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Retina. 2004 Feb;24(1):41-50. doi: 10.1097/00006982-200402000-00007."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.\n\nTo compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.", "DetailedDescription"=>"Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with cluster of differentiation 4 (CD4) + T-cell counts < 100 cells/µL and often < 50 cells/µL.\n\nAll currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body. Discontinuation of therapy is associated with a prompt relapse of the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis generally occurs, at least with systemically administered anti-CMV drugs.\n\nThe first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet. Both are given by daily intravenous infusions and therefore require central venous catheters. The development of newer treatments has focused not only on efficacious treatments, but also on treatments that do not require central venous catheters. Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and intravenous cidofovir.\n\nIn vitro data suggest that combination therapies are synergistic in inhibiting viral replication; these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure.\n\nThe Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis. Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2 weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate that regimen, an alternative systemic regimen will be recommended.\n\nStudy outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss. The study will also assess other variables including mortality, blood CMV and HIV load, quality of life, and medical costs.\n\nTreatment assignment will not be masked to either patients or clinicians; however, reading of fundus photographs to determine both change in retinal involvement and progression will be masked."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion criteria:\n\nAge 13 years or older\nDiagnosis of AIDS according to current Centers for Disease Control and Prevention (CDC) definition\nDiagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of any zone or amount of retina is allowed)\nBest corrected visual acuity of 20/100 or better in at least one eye\nAt least one lesion 750 cells/µL or greater\nPlatelet count 50,000 cells/µL or greater\nWillingness and ability, with the assistance of a caregiver if necessary to comply with treatment and follow up procedures\nWillingness of all men and women of childbearing potential to practice adequate birth control to prevent pregnancies during the study and for 3 months afterwards\nCollection of all baseline data within 5 days prior to randomization\nSigned consent statement\n\nExclusion criteria:\n\nMedia opacities that preclude visualization of the fundus of all otherwise eligible eyes\nTreatment for CMV retinitis with the ganciclovir intraocular implant within 9 months of study entry\nMedical problems or drug or alcohol abuse sufficient to hinder adherence to treatment or follow up procedures\nUnwillingness to refrain from breast-feeding during the study and for 3 months afterwards"}, "IdentificationModule"=>{"NCTId"=>"NCT00000143", "Acronym"=>"GCCRT", "BriefTitle"=>"Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Johns Hopkins Bloomberg School of Public Health"}, "OfficialTitle"=>"Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NEI-42"}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Ganciclovir implant and oral ganciclovir", "ArmGroupDescription"=>"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Device: Ganciclovir implant and oral ganciclovir"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Cidofovir IV (Intravenous)", "ArmGroupDescription"=>"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Cidofovir intravenous"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Ganciclovir implant and oral ganciclovir", "InterventionType"=>"Device", "InterventionDescription"=>"oral ganciclovir, 1 gm three times daily", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Vitraset"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Ganciclovir implant and oral ganciclovir"]}}, {"InterventionName"=>"Cidofovir intravenous", "InterventionType"=>"Drug", "InterventionDescription"=>"intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Vistide"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Cidofovir IV (Intravenous)"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"92697-4375", "LocationCity"=>"Irvine", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Ophthalmology, University of California, Irvine"}, {"LocationZip"=>"92093-0946", "LocationCity"=>"La Jolla", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Shiley Eye Center Center, 0946, University of California, San Diego"}, {"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"LAC/USC Medical Center, 5P21 Rand Schrader Clinic"}, {"LocationZip"=>"90095-7003", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Jules Stein Eye Institute, University of California, Los Angeles"}, {"LocationZip"=>"94143", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Beckman Vision Center, University of California, San Francisco"}, {"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Bascom Palmer Eye Institute, University of Miami"}, {"LocationZip"=>"33612-4799", "LocationCity"=>"Tampa", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"University of South Florida, MDC Box 21"}, {"LocationZip"=>"30322", "LocationCity"=>"Atlanta", "LocationState"=>"Georgia", "LocationCountry"=>"United States", "LocationFacility"=>"The Emory Clinic, Emory University"}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Ophthalmology, Northwestern University"}, {"LocationZip"=>"46202-2879", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Division of Infectious Diseases, Indiana University, Indianapolis"}, {"LocationZip"=>"70112", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"LSU Eye Center, Louisiana State University Medical Center"}, {"LocationZip"=>"21287-9217", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine"}, {"LocationZip"=>"02114", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital"}, {"LocationZip"=>"07103-2499", "LocationCity"=>"Newark", "LocationState"=>"New Jersey", "LocationCountry"=>"United States", "LocationFacility"=>"UMDNJ-New Jersey Medical School"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Ophthalmology, New York University Medical Center"}, {"LocationZip"=>"10021", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Ophthalmology, New York Hospital-Cornell Medical Center"}, {"LocationZip"=>"10029-6574", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Ophthalmology, Mount Sinai School of Medicine"}, {"LocationZip"=>"27599-7030", "LocationCity"=>"Chapel Hill", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"University of North Carolina at Chapel Hill"}, {"LocationZip"=>"77030", "LocationCity"=>"Houston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Cullen Eye Institute, Baylor College of Medicine"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Douglas Jabs, MD", "OverallOfficialRole"=>"Study Chair", "OverallOfficialAffiliation"=>"SOCA Chairman's Office"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"Yes"}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Johns Hopkins Bloomberg School of Public Health", "LeadSponsorClass"=>"OTHER"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
