Nctid:
NCT00000950
Payload:
{"FullStudy"=>{"Rank"=>474664, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014376", "ConditionMeshTerm"=>"Tuberculosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000009164", "ConditionAncestorTerm"=>"Mycobacterium Infections"}, {"ConditionAncestorId"=>"D000000193", "ConditionAncestorTerm"=>"Actinomycetales Infections"}, {"ConditionAncestorId"=>"D000016908", "ConditionAncestorTerm"=>"Gram-Positive Bacterial Infections"}, {"ConditionAncestorId"=>"D000001424", "ConditionAncestorTerm"=>"Bacterial Infections"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16817", "ConditionBrowseLeafName"=>"Tuberculosis", "ConditionBrowseLeafAsFound"=>"Tuberculosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12515", "ConditionBrowseLeafName"=>"Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19100", "ConditionBrowseLeafName"=>"AIDS-Related Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11809", "ConditionBrowseLeafName"=>"Mycobacterium Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4412", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18942", "ConditionBrowseLeafName"=>"Gram-Positive Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11826", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4411", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000011736", "InterventionMeshTerm"=>"Pyridoxine"}, {"InterventionMeshId"=>"D000025101", "InterventionMeshTerm"=>"Vitamin B 6"}, {"InterventionMeshId"=>"D000012293", "InterventionMeshTerm"=>"Rifampin"}, {"InterventionMeshId"=>"D000007538", "InterventionMeshTerm"=>"Isoniazid"}, {"InterventionMeshId"=>"D000011718", "InterventionMeshTerm"=>"Pyrazinamide"}, {"InterventionMeshId"=>"D000004977", "InterventionMeshTerm"=>"Ethambutol"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000904", "InterventionAncestorTerm"=>"Antibiotics, Antitubercular"}, {"InterventionAncestorId"=>"D000000995", "InterventionAncestorTerm"=>"Antitubercular Agents"}, {"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000007917", "InterventionAncestorTerm"=>"Leprostatic Agents"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000065695", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2B6 Inducers"}, {"InterventionAncestorId"=>"D000065693", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inducers"}, {"InterventionAncestorId"=>"D000065696", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C8 Inducers"}, {"InterventionAncestorId"=>"D000065697", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C19 Inducers"}, {"InterventionAncestorId"=>"D000065698", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C9 Inducers"}, {"InterventionAncestorId"=>"D000065701", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP3A Inducers"}, {"InterventionAncestorId"=>"D000054872", "InterventionAncestorTerm"=>"Fatty Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000000960", "InterventionAncestorTerm"=>"Hypolipidemic Agents"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000057847", "InterventionAncestorTerm"=>"Lipid Regulating Agents"}, {"InterventionAncestorId"=>"D000014803", "InterventionAncestorTerm"=>"Vitamin B Complex"}, {"InterventionAncestorId"=>"D000014815", "InterventionAncestorTerm"=>"Vitamins"}, {"InterventionAncestorId"=>"D000018977", "InterventionAncestorTerm"=>"Micronutrients"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M14808", "InterventionBrowseLeafName"=>"Rifampin", "InterventionBrowseLeafAsFound"=>"Held", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M10260", "InterventionBrowseLeafName"=>"Isoniazid", "InterventionBrowseLeafAsFound"=>"Airway Pressure", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M14261", "InterventionBrowseLeafName"=>"Pyrazinamide", "InterventionBrowseLeafAsFound"=>"Termination", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M7815", "InterventionBrowseLeafName"=>"Ethambutol", "InterventionBrowseLeafAsFound"=>"Iodixanol", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M14279", "InterventionBrowseLeafName"=>"Pyridoxine", "InterventionBrowseLeafAsFound"=>"Linac", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M14273", "InterventionBrowseLeafName"=>"Pyridoxal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M22716", "InterventionBrowseLeafName"=>"Vitamin B 6", "InterventionBrowseLeafAsFound"=>"Linac", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4001", "InterventionBrowseLeafName"=>"Antitubercular Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17248", "InterventionBrowseLeafName"=>"Vitamins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17236", "InterventionBrowseLeafName"=>"Vitamin B Complex", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3914", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3968", "InterventionBrowseLeafName"=>"Hypolipidemic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28573", "InterventionBrowseLeafName"=>"Lipid Regulating Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8308", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20699", "InterventionBrowseLeafName"=>"Micronutrients", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16575", "InterventionBrowseLeafName"=>"Trace Elements", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T461", "InterventionBrowseLeafName"=>"Pyridoxine", "InterventionBrowseLeafAsFound"=>"Sargramostim", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T459", "InterventionBrowseLeafName"=>"Pyridoxal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T474", "InterventionBrowseLeafName"=>"Vitamin B6", "InterventionBrowseLeafAsFound"=>"Linac", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T448", "InterventionBrowseLeafName"=>"Folate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T446", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T475", "InterventionBrowseLeafName"=>"Vitamin B9", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Lipid Regulating Agents", "InterventionBrowseBranchAbbrev"=>"Lipd"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"50"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2011", "LastUpdateSubmitDate"=>"March 1, 2011", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 2, 2011", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"May 2002", "PrimaryCompletionDateType"=>"Actual"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Tuberculosis", "Isoniazid", "Pyrazinamide", "Pyridoxine", "Rifampin", "AIDS-Related Opportunistic Infections", "Drug Therapy, Combination", "Ethambutol", "Acquired Immunodeficiency Syndrome", "Antitubercular Agents"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "Tuberculosis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"14765350", "ReferenceType"=>"background", "ReferenceCitation"=>"Perlman DC, Segal Y, Rosenkranz S, Rainey PM, Peloquin CA, Remmel RP, Chirgwin K, Salomon N, Hafner R; ACTG 309 Team. The clinical pharmacokinetics of pyrazinamide in HIV-infected persons with tuberculosis. Clin Infect Dis. 2004 Feb 15;38(4):556-64. doi: 10.1086/381096. Epub 2004 Jan 28."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.", "DetailedDescription"=>"Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly)."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this study if you:\n\nAre HIV-positive and have tuberculosis.\nAre 13 years of age or older.\nHave written, informed consent of parent or guardian if you are under 18 years of age.\nAgree to practice abstinence or use barrier methods of birth control during the study.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\nHave any other disorder or condition which might cause study treatment to be undesirable.\nAre pregnant."}, "IdentificationModule"=>{"NCTId"=>"NCT00000950", "BriefTitle"=>"Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 309"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Ethambutol hydrochloride", "InterventionType"=>"Drug"}, {"InterventionName"=>"Isoniazid", "InterventionType"=>"Drug"}, {"InterventionName"=>"Pyrazinamide", "InterventionType"=>"Drug"}, {"InterventionName"=>"Pyridoxine hydrochloride", "InterventionType"=>"Drug"}, {"InterventionName"=>"Rifampin", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"900331079", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Southern California / LA County USC Med Ctr"}, {"LocationZip"=>"90502", "LocationCity"=>"Torrance", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Harbor UCLA Med Ctr"}, {"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"University of Miami (Pediatric)"}, {"LocationZip"=>"30308", "LocationCity"=>"Atlanta", "LocationState"=>"Georgia", "LocationCountry"=>"United States", "LocationFacility"=>"Emory Univ"}, {"LocationZip"=>"96816", "LocationCity"=>"Honolulu", "LocationState"=>"Hawaii", "LocationCountry"=>"United States", "LocationFacility"=>"Queens Med Ctr"}, {"LocationZip"=>"96816", "LocationCity"=>"Honolulu", "LocationState"=>"Hawaii", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Hawaii"}, {"LocationZip"=>"70112", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane Univ School of Medicine"}, {"LocationZip"=>"112032098", "LocationCity"=>"Brooklyn", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY / Health Sciences Ctr at Brooklyn"}, {"LocationZip"=>"10003", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Med Ctr"}, {"LocationZip"=>"10021", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr"}, {"LocationZip"=>"10029", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Mount Sinai Med Ctr"}, {"LocationZip"=>"441091998", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"MetroHealth Med Ctr"}, {"LocationZip"=>"19104", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Pennsylvania at Philadelphia"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Keith Chirgwin", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"David Perlman", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}
