Nctid:
NCT00000799
Payload:
{"hasResults"=>false, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "relevance"=>"LOW"}, {"id"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "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"=>"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"=>"D000011339", "term"=>"Probenecid"}], "ancestors"=>[{"id"=>"D000014528", "term"=>"Uricosuric Agents"}, {"id"=>"D000006074", "term"=>"Gout Suppressants"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M14212", "name"=>"Probenecid", "asFound"=>"Camp", "relevance"=>"HIGH"}, {"id"=>"M1785", "name"=>"Cidofovir", "asFound"=>"Endoscopic Retrograde Cholangiopancreatography", "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"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>100}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-10", "completionDateStruct"=>{"date"=>"1996-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-10-31", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2012-11-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Retinitis", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome", "Antiviral Agents", "cidofovir"], "conditions"=>["Cytomegalovirus Retinitis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9036798", "type"=>"BACKGROUND", "citation"=>"Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.", "detailedDescription"=>"In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Oral trimethoprim/sulfamethoxazole.\n* Aerosolized pentamidine.\n* Dapsone.\n* Fluconazole.\n* Ketoconazole.\n* Itraconazole.\n* Rifabutin.\n* Filgrastim (G-CSF).\n* Antiretroviral agents.\n\nPatients must have:\n\n* AIDS by CDC criteria.\n* CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field.\n\nPrior Medication:\n\nAllowed:\n\n* Prophylaxis with anti-CMV agents.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.\n* Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.\n\nPatients with the following prior conditions are excluded:\n\n* History of renal disease or renal dialysis.\n* History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.\n* History of clinically significant probenecid allergy.\n\nPrior Medication:\n\nExcluded:\n\n* Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.\n* Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.\n\nDrug or alcohol abuse sufficient to hinder compliance with study."}, "identificationModule"=>{"nctId"=>"NCT00000799", "briefTitle"=>"HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol", "orgStudyIdInfo"=>{"id"=>"ACTG 281"}, "secondaryIdInfos"=>[{"id"=>"GS-93-105"}, {"id"=>"FDA 231A"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cidofovir", "type"=>"DRUG"}, {"name"=>"Probenecid", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"920930946", "city"=>"La Jolla", "state"=>"California", "country"=>"United States", "facility"=>"UCSD - Shiley Eye Ctr / SOCA", "geoPoint"=>{"lat"=>32.84727, "lon"=>-117.2742}}, {"zip"=>"900957003", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA - Jules Stein Eye Institute / SOCA", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94143", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ / SOCA", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"212879217", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp / SOCA", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York Univ Med Ctr / SOCA", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"275997030", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina / SOCA", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Gilead Sciences", "class"=>"INDUSTRY"}]}}}
