Nctid:
NCT00000819
Payload:
{"FullStudy"=>{"Rank"=>474080, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000016263", "ConditionMeshTerm"=>"AIDS-Associated Nephropathy"}, {"ConditionMeshId"=>"D000007674", "ConditionMeshTerm"=>"Kidney Diseases"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000015658", "ConditionAncestorTerm"=>"HIV Infections"}, {"ConditionAncestorId"=>"D000086982", "ConditionAncestorTerm"=>"Blood-Borne Infections"}, {"ConditionAncestorId"=>"D000003141", "ConditionAncestorTerm"=>"Communicable Diseases"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000015229", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases, Viral"}, {"ConditionAncestorId"=>"D000012749", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases"}, {"ConditionAncestorId"=>"D000016180", "ConditionAncestorTerm"=>"Lentivirus Infections"}, {"ConditionAncestorId"=>"D000012192", "ConditionAncestorTerm"=>"Retroviridae Infections"}, {"ConditionAncestorId"=>"D000012327", "ConditionAncestorTerm"=>"RNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000007153", "ConditionAncestorTerm"=>"Immunologic Deficiency Syndromes"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000014570", "ConditionAncestorTerm"=>"Urologic Diseases"}, {"ConditionAncestorId"=>"D000052776", "ConditionAncestorTerm"=>"Female Urogenital Diseases"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"ConditionAncestorId"=>"D000052801", "ConditionAncestorTerm"=>"Male Urogenital Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10388", "ConditionBrowseLeafName"=>"Kidney Diseases", "ConditionBrowseLeafAsFound"=>"Nephropathy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3425", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18403", "ConditionBrowseLeafName"=>"AIDS-Associated Nephropathy", "ConditionBrowseLeafAsFound"=>"AIDS-Associated Nephropathy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2594", "ConditionBrowseLeafName"=>"Blood-Borne Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15248", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17623", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases, Viral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18330", "ConditionBrowseLeafName"=>"Lentivirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14716", "ConditionBrowseLeafName"=>"Retroviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17212", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14839", "ConditionBrowseLeafName"=>"RNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2877", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17009", "ConditionBrowseLeafName"=>"Urologic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26783", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13817", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8089", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26785", "ConditionBrowseLeafName"=>"Male Urogenital Diseases", "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"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000011241", "InterventionMeshTerm"=>"Prednisone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000893", "InterventionAncestorTerm"=>"Anti-Inflammatory Agents"}, {"InterventionAncestorId"=>"D000005938", "InterventionAncestorTerm"=>"Glucocorticoids"}, {"InterventionAncestorId"=>"D000006728", "InterventionAncestorTerm"=>"Hormones"}, {"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018931", "InterventionAncestorTerm"=>"Antineoplastic Agents, Hormonal"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M13811", "InterventionBrowseLeafName"=>"Prednisone", "InterventionBrowseLeafAsFound"=>"Syndrome", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3907", "InterventionBrowseLeafName"=>"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8737", "InterventionBrowseLeafName"=>"Glucocorticoids", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9478", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20656", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Hormonal", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Inflammatory Agents", "InterventionBrowseBranchAbbrev"=>"Infl"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"54"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"September 1996", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 29, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["AIDS-Related Complex", "Prednisone", "AIDS-Associated Nephropathy"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "AIDS-Associated Nephropathy"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Kalayjian R, Phinney M, Austen J, Gripshover B, Carey J, Rahman M, Weigel K, Smith MC. Prednisone improves renal function in HIV-associated nephropathy (HIVAN). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:154"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance.\n\nHIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.", "DetailedDescription"=>"HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.\n\nPatients are randomized to receive prednisone or placebo for 11 weeks, followed by 13 weeks of observation."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\nHIV infection.\nBiopsy-confirmed glomerulosclerosis and/or mesangial proliferation within 90 days prior to study entry.\nMild to severe renal insufficiency that is stable or worsening.\nNo AIDS-defining opportunistic infections or malignancies.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nPoorly controlled hypertension or diabetes mellitus.\nPeptic ulcer disease with gastrointestinal bleeding.\nActive symptomatic bacterial, protozoal, fungal, or viral infections (other than HIV disease).\nSuperimposed renal disease that is due to processes other than focal glomerulosclerosis or mesangial proliferation, including but not limited to obstructive uropathy, acute tubular necrosis, and prerenal azotemia.\nEmotional problems sufficient to prevent adequate compliance with study therapy.\n\nConcurrent Medication:\n\nExcluded:\n\nIV amphotericin B.\nIV aminoglycosides.\nIV foscarnet.\nIV pentamidine.\nTrimethoprim > 200 mg/day.\nNonsteroidal anti-inflammatory agents.\nAngiotensin converting enzyme inhibitors (benzapril, captopril, enalapril, fosinopril, lisinopril, guinapril, and ramipril) except for refractory hypertension.\n\nConcurrent Treatment:\n\nExcluded:\n\nIodinated radiocontrast dye.\n\nPatients with the following prior conditions are excluded:\n\nActive pulmonary disease on chest radiograph within 60 days prior to study entry.\nCMV retinitis on ophthalmologic evaluation within 60 days prior to study entry.\nPositive blood culture for mycobacteria 10-60 days prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\nPrior corticosteroid therapy for HIVAN.\nCorticosteroid therapy for any indication within 30 days prior to study entry.\nContinuous nonsteroidal anti-inflammatory agents for more than 15 days during the 4 weeks prior to study entry.\n\nPrior Treatment:\n\nExcluded within 30 days prior to study entry:\n\nDialysis for acute or chronic renal failure.\nIodinated radiocontrast dye.\n\nRequired:\n\nStable antiretroviral therapy with AZT alone or in combination with ddI, ddC, or d4T for at least 4 weeks unless contraindicated.\nPCP prophylaxis with TMP/SMX, pentamidine aerosol, dapsone, or atovaquone.\nMAC prophylaxis with rifabutin or clarithromycin for patients with CD4 count < 100 cells/mm3.\nMycobacterium tuberculosis prophylaxis with isoniazid or another accepted regimen for patients with a positive or previously positive tuberculin test and for anergic patients who are known household or close contacts of infectious TB patients or who are from groups in which the prevalence of TB is 10 percent or higher.\nInvestigational drugs unless exempted by protocol chair.\nOther medications unless expressly prohibited.\n\nActive alcohol or drug abuse."}, "IdentificationModule"=>{"NCTId"=>"NCT00000819", "BriefTitle"=>"A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 271"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11247", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Prednisone", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA CARE Center CRS"}, {"LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Ucsf Aids Crs"}, {"LocationZip"=>"90502", "LocationCity"=>"Torrance", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Harbor-UCLA Med. Ctr. CRS"}, {"LocationZip"=>"46202", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic"}, {"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Adult AIDS CRS"}, {"LocationZip"=>"10003", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Med. Ctr. (Mt. Sinai)"}, {"LocationZip"=>"44106", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Case CRS"}, {"LocationZip"=>"44109", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"MetroHealth CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Kalayjian R", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Smith MC", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Lederman M", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Upjohn", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}