Nctid:
NCT00002437
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"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"=>"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"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"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"=>"D000077404", "term"=>"Cidofovir"}, {"id"=>"D011339", "term"=>"Probenecid"}], "ancestors"=>[{"id"=>"D014528", "term"=>"Uricosuric Agents"}, {"id"=>"D006074", "term"=>"Gout Suppressants"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M14212", "name"=>"Probenecid", "asFound"=>"Ml/kg/h", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M1785", "name"=>"Cidofovir", "asFound"=>"FMD", "relevance"=>"HIGH"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>48}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1994-11", "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", "Probenecid", "Drug Therapy, Combination", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome", "Antiviral Agents", "cidofovir"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Lalezari J, et al. A phase II/III randomized study of immediate versus deferred intravenous (IV) cidofovir (CDV, HPMPC) for the treatment of peripheral CMV retinitis (CMV-R) in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:170"}]}, "descriptionModule"=>{"briefSummary"=>"To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.", "detailedDescription"=>"Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretroviral agents.\n* Oral trimethoprim/sulfamethoxazole.\n* Aerosolized pentamidine.\n* Dapsone.\n* Fluconazole.\n* Rifabutin.\n* Filgrastim (G-CSF).\n* p24 vaccine.\n\nPatients must have:\n\n* Diagnosis of AIDS by CDC criteria.\n* Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis.\n* Visual acuity in the affected eye of \\>= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance.\n* Life expectancy of at least 3 months.\n* Consent of parent or guardian in patients less than 18 years of age.\n\nPrior Medication:\n\nAllowed:\n\n* Acyclovir.\n* Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Media opacity that precludes visualization of the fundus of both eyes.\n* Retinal detachment.\n* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.\n* Active medical problems considered sufficient to hinder study compliance.\n* Known clinically significant allergy to probenecid.\n\nConcurrent Medication:\n\nExcluded:\n\n* Acyclovir (may be reinstituted following development of herpetic lesions).\n* Ganciclovir.\n* Foscarnet.\n* Amphotericin B.\n* Diuretics.\n* Aminoglycoside antibiotics.\n* CMV hyperimmune immunoglobulin.\n* Intravenous pentamidine.\n* Other nephrotoxic agents.\n* Other investigational drugs with potential nephrotoxicity.\n\nPrior Medication:\n\nExcluded:\n\n* Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis).\n\nExcluded within 1 week prior to study entry:\n\n* Amphotericin B.\n* Vidarabine.\n* Other nephrotoxic agents.\n* Aminoglycoside antibiotics.\n* Intravenous pentamidine. Drug or alcohol abuse."}, "identificationModule"=>{"nctId"=>"NCT00002437", "briefTitle"=>"The Safety and Effectiveness of Cidofovir 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 Phase II/III Study of the Safety and Efficacy of 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) for the Treatment of Peripheral Cytomegalovirus Retinitis in Patients With AIDS", "orgStudyIdInfo"=>{"id"=>"216A"}, "secondaryIdInfos"=>[{"id"=>"GS-93-106"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cidofovir", "type"=>"DRUG"}, {"name"=>"Probenecid", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92668", "city"=>"Orange", "state"=>"California", "country"=>"United States", "facility"=>"UCI Med Ctr", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Mount Zion Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"085406681", "city"=>"Princeton", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Besselaar Associates", "geoPoint"=>{"lat"=>40.34872, "lon"=>-74.65905}}, {"zip"=>"14607", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Med Ctr", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"27599", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina Hosps", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"78284", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Audie L Murphy Veterans Administration Hosp", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"city"=>"London SW 10", "country"=>"United Kingdom", "facility"=>"Charing Cross and Westminster Med School"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gilead Sciences", "class"=>"INDUSTRY"}}}}
