Nctid:
NCT00000135
Payload:
{"hasResults"=>true, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000017726", "term"=>"Cytomegalovirus Retinitis"}, {"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"=>"D000015828", "term"=>"Eye Infections, Viral"}, {"id"=>"D000015817", "term"=>"Eye Infections"}, {"id"=>"D000003586", "term"=>"Cytomegalovirus Infections"}, {"id"=>"D000006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"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"=>{"browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M4230", "name"=>"Antibodies, Monoclonal", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "resultsSection"=>{"moreInfoModule"=>{"pointOfContact"=>{"email"=>"cmeinert@jhsph.edu", "phone"=>"410-955-8198", "title"=>"Curtis Meinert, PhD", "organization"=>"Johns Hopkins University"}, "certainAgreement"=>{"restrictionType"=>"OTHER", "piSponsorEmployee"=>false, "restrictiveAgreement"=>true}}, "adverseEventsModule"=>{"timeFrame"=>"11 months", "eventGroups"=>[{"id"=>"EG000", "title"=>"MSL-109", "description"=>"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.", "otherNumAtRisk"=>104, "otherNumAffected"=>0, "seriousNumAtRisk"=>104, "seriousNumAffected"=>0}, {"id"=>"EG001", "title"=>"Placebo", "description"=>"Placebo administered intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.", "otherNumAtRisk"=>105, "otherNumAffected"=>0, "seriousNumAtRisk"=>105, "seriousNumAffected"=>0}], "frequencyThreshold"=>"0"}, "outcomeMeasuresModule"=>{"outcomeMeasures"=>[{"type"=>"PRIMARY", "title"=>"Mortality Rate", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"104", "groupId"=>"OG000"}, {"value"=>"105", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"MSL-109", "description"=>"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."}, {"id"=>"OG001", "title"=>"Placebo", "description"=>"Placebo administered intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"0.68", "groupId"=>"OG000"}, {"value"=>"0.31", "groupId"=>"OG001"}]}]}], "paramType"=>"NUMBER", "timeFrame"=>"All patients enrolled were followed for a 17 month period or until a common study closing date", "description"=>"to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .", "unitOfMeasure"=>"deaths per person-year", "reportingStatus"=>"POSTED"}]}, "participantFlowModule"=>{"groups"=>[{"id"=>"FG000", "title"=>"MSL-109", "description"=>"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."}, {"id"=>"FG001", "title"=>"Placebo", "description"=>"Placebo administered intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."}], "periods"=>[{"title"=>"Overall Study", "milestones"=>[{"type"=>"STARTED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"104"}, {"groupId"=>"FG001", "numSubjects"=>"105"}]}, {"type"=>"COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"77"}, {"groupId"=>"FG001", "numSubjects"=>"91"}]}, {"type"=>"NOT COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"27"}, {"groupId"=>"FG001", "numSubjects"=>"14"}]}], "dropWithdraws"=>[{"type"=>"Death", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"27"}, {"groupId"=>"FG001", "numSubjects"=>"14"}]}]}], "recruitmentDetails"=>"Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis. Primary drug therapy for CMV retinitis was determined by the treating physician.", "preAssignmentDetails"=>"Two hundred and nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter, phase 2/3, randomized, placebo controlled clinical trial. Patients received adjuvant treatment with MSL-109, 60mg intravenously every 2 weeks, or placebo,."}, "baselineCharacteristicsModule"=>{"denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"104", "groupId"=>"BG000"}, {"value"=>"105", "groupId"=>"BG001"}, {"value"=>"209", "groupId"=>"BG002"}]}], "groups"=>[{"id"=>"BG000", "title"=>"MSL-109", "description"=>"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."}, {"id"=>"BG001", "title"=>"Placebo", "description"=>"Placebo administered intravenous infusion every 2 weeks 60 mg.\n\nMSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."}, {"id"=>"BG002", "title"=>"Total", "description"=>"Total of all reporting groups"}], "measures"=>[{"title"=>"Age, Categorical", "classes"=>[{"categories"=>[{"title"=>"<=18 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}]}, {"title"=>"Between 18 and 65 years", "measurements"=>[{"value"=>"104", "groupId"=>"BG000"}, {"value"=>"105", "groupId"=>"BG001"}, {"value"=>"209", "groupId"=>"BG002"}]}, {"title"=>">=65 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Sex: Female, Male", "classes"=>[{"categories"=>[{"title"=>"Female", "measurements"=>[{"value"=>"11", "groupId"=>"BG000"}, {"value"=>"11", "groupId"=>"BG001"}, {"value"=>"22", "groupId"=>"BG002"}]}, {"title"=>"Male", "measurements"=>[{"value"=>"93", "groupId"=>"BG000"}, {"value"=>"94", "groupId"=>"BG001"}, {"value"=>"187", "groupId"=>"BG002"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Region of Enrollment", "classes"=>[{"title"=>"United States", "categories"=>[{"measurements"=>[{"value"=>"104", "groupId"=>"BG000"}, {"value"=>"105", "groupId"=>"BG001"}, {"value"=>"209", "groupId"=>"BG002"}]}]}], "paramType"=>"NUMBER", "unitOfMeasure"=>"participants"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2", "PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>209}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2015-07", "completionDateStruct"=>{"date"=>"1996-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-10-14", "studyFirstSubmitDate"=>"1999-09-23", "resultsFirstSubmitDate"=>"2015-06-12", "studyFirstSubmitQcDate"=>"1999-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2015-11-17", "type"=>"ESTIMATED"}, "resultsFirstSubmitQcDate"=>"2015-10-14", "studyFirstPostDateStruct"=>{"date"=>"1999-09-24", "type"=>"ESTIMATED"}, "resultsFirstPostDateStruct"=>{"date"=>"2015-11-17", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1996-08", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mortality Rate", "timeFrame"=>"All patients enrolled were followed for a 17 month period or until a common study closing date", "description"=>"to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. ."}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"conditions"=>["HIV Infections", "Cytomegalovirus Retinitis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9400786", "type"=>"RESULT", "citation"=>"MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: the Monoclonal Antibody Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group. AIDS Clinical Trials Group. Arch Ophthalmol. 1997 Dec;115(12):1528-36. Erratum In: Arch Ophthalmol 1998 Mar;116(3):296."}, {"pmid"=>"11919489", "type"=>"RESULT", "citation"=>"Jabs DA, Gilpin AM, Min YI, Erice A, Kempen JH, Quinn TC; Studies of Ocular Complications of AIDS Research Group. HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial. AIDS. 2002 Apr 12;16(6):877-87. doi: 10.1097/00002030-200204120-00007."}, {"pmid"=>"12232843", "type"=>"RESULT", "citation"=>"Davidson M, Min YI, Holbrook JT, Van Natta M, Quinn TC, Murphy RL, Welch W, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Influence of filgrastim (granulocyte colony-stimulating factor) on human immunodeficiency virus type 1 RNA in patients with cytomegalovirus retinitis. J Infect Dis. 2002 Oct 1;186(7):1013-8. doi: 10.1086/342956. Epub 2002 Aug 29."}, {"pmid"=>"12559647", "type"=>"RESULT", "citation"=>"Gilpin AM, Holbrook JT, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial. Control Clin Trials. 2003 Feb;24(1):92-8. doi: 10.1016/s0197-2456(02)00268-4."}, {"pmid"=>"31042791", "type"=>"DERIVED", "citation"=>"Holland GN, Van Natta ML, Goldenberg DT, Ritts R Jr, Danis RP, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Relationship Between Opacity of Cytomegalovirus Retinitis Lesion Borders and Severity of Immunodeficiency Among People With AIDS. Invest Ophthalmol Vis Sci. 2019 May 1;60(6):1853-1862. doi: 10.1167/iovs.18-26517."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.", "detailedDescription"=>"CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. As of September 1996, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment (induction) to control the infection followed by long-term lower dose treatment (maintenance) to prevent relapse. Ganciclovir is available in both intravenous and oral formulations, foscarnet only in an intravenous formulation, and cidofovir is given by intermittent intravenous administration. A surgically implanted intraocular sustained-release ganciclovir device (Vitrasert) is also approved by the FDA for the treatment of CMV retinitis.\n\nDespite the use of continuous maintenance therapy, given enough time, all patients with CMV retinitis on systemically administered drugs relapse. Preliminary studies suggested that the anti-CMV monoclonal antibody, MSL-109, when administered in conjunction with ganciclovir, markedly prolonged the time to relapse. Therefore, a randomized controlled clinical trial evaluating MSL-109 as adjunct therapy was conducted.\n\nThe MACRT was a randomized, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis. Patients with CMV retinitis, both those newly diagnosed and those suffering a relapse with active retinitis, were eligible. Primary therapy (e.g., ganciclovir, foscarnet, etc.) was determined by the treating local physician. The patients enrolled in the trial were randomized to either MSL-109 or placebo, administered as a rapid intravenous infusion every 2 weeks. Outcomes included survival, retinitis progression, change in amount of retinal area involved by CMV, loss of visual function (acuity and field), and morbidity."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion criteria:\n\n* 13 years or older at entry\n* Diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC) definition\n* Diagnosis of active CMV retinitis as determined by a SOCA-certified ophthalmologist at time of enrollment\n* At least one lesion whose size is one-quarter or more optic disc area\n* Currently receiving (for relapsed patients) or scheduled to receive (for newly diagnosed patients) drugs for primary treatment of CMV retinitis that are not contraindicated for use with MSL-109\n* Visual acuity, in at least one eye that meets other eligibility criteria, of 3 or more letters on ETDRS chart at 1 meter distance (Snellen equivalent 5/200). Patients with poorer visual acuity may be enrolled if the visual acuity impairment is possibly reversible (eg, due to optic disc edema) and vision is at least light perception in that eye\n* Karnofsky score of 60 or more\n* Willingness and ability, with the assistance of a caregiver if necessary, to comply with treatment and follow up procedures\n* signed consent statement\n\nExclusion criteria:\n\n* Current treatment with intravenous immune globulin (IVIG), CMV immune globulin (CMVIG), alpha-interferon (alpha-IFN), gamma-interferon (gamma-IFN) or interleukin-2 (IL-2)\n* Media opacity that precludes visualization of the fundus in all eyes meeting eligibility criteria\n* Active medical problems, including drug or alcohol abuse, that are considered sufficient to hinder compliance with treatment or follow up procedures\n* Retinal detachment, not scheduled for surgical repair, in all eyes meeting other eligibility criteria"}, "identificationModule"=>{"nctId"=>"NCT00000135", "acronym"=>"MACRT", "briefTitle"=>"Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins Bloomberg School of Public Health"}, "officialTitle"=>"Monoclonal Antibody CMV Retinitis Trial (MACRT)", "orgStudyIdInfo"=>{"id"=>"NEI-34"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"MSL-109", "description"=>"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.", "interventionNames"=>["Drug: MSL-109"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Placebo administered intravenous infusion every 2 weeks 60 mg.", "interventionNames"=>["Other: Placebo"]}], "interventions"=>[{"name"=>"MSL-109", "type"=>"DRUG", "otherNames"=>["Monoclonal antibodies"], "description"=>"60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.", "armGroupLabels"=>["MSL-109"]}, {"name"=>"Placebo", "type"=>"OTHER", "description"=>"60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.", "armGroupLabels"=>["Placebo"]}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins Bloomberg School of Public Health", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
