Nctid:
NCT00000998
Payload:
{"FullStudy"=>{"Rank"=>498334, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000011014", "ConditionMeshTerm"=>"Pneumonia"}, {"ConditionMeshId"=>"D000011020", "ConditionMeshTerm"=>"Pneumonia, Pneumocystis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000012141", "ConditionAncestorTerm"=>"Respiratory Tract Infections"}, {"ConditionAncestorId"=>"D000008171", "ConditionAncestorTerm"=>"Lung Diseases"}, {"ConditionAncestorId"=>"D000012140", "ConditionAncestorTerm"=>"Respiratory Tract Diseases"}, {"ConditionAncestorId"=>"D000008172", "ConditionAncestorTerm"=>"Lung Diseases, Fungal"}, {"ConditionAncestorId"=>"D000009181", "ConditionAncestorTerm"=>"Mycoses"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}, {"ConditionAncestorId"=>"D000016720", "ConditionAncestorTerm"=>"Pneumocystis Infections"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13904", "ConditionBrowseLeafName"=>"Pneumonia", "ConditionBrowseLeafAsFound"=>"Pneumonia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13910", "ConditionBrowseLeafName"=>"Pneumonia, Pneumocystis", "ConditionBrowseLeafAsFound"=>"Pneumonia, Pneumocystis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12825", "ConditionBrowseLeafName"=>"Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19410", "ConditionBrowseLeafName"=>"AIDS-Related Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14978", "ConditionBrowseLeafName"=>"Respiratory Tract Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11168", "ConditionBrowseLeafName"=>"Lung Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14977", "ConditionBrowseLeafName"=>"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11169", "ConditionBrowseLeafName"=>"Lung Diseases, Fungal", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12136", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4722", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4721", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19082", "ConditionBrowseLeafName"=>"Pneumocystis Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T4598", "ConditionBrowseLeafName"=>"Pneumocystis Jirovecii Pneumonia", "ConditionBrowseLeafAsFound"=>"Pneumocystis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4599", "ConditionBrowseLeafName"=>"Pneumocystosis", "ConditionBrowseLeafAsFound"=>"Pneumocystis", "ConditionBrowseLeafRelevance"=>"high"}]}, "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"}, {"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000002955", "InterventionMeshTerm"=>"Leucovorin"}, {"InterventionMeshId"=>"D000016597", "InterventionMeshTerm"=>"Trimetrexate"}, {"InterventionMeshId"=>"D000002118", "InterventionMeshTerm"=>"Calcium"}, {"InterventionMeshId"=>"D000058766", "InterventionMeshTerm"=>"Levoleucovorin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000077264", "InterventionAncestorTerm"=>"Calcium-Regulating Hormones and Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000931", "InterventionAncestorTerm"=>"Antidotes"}, {"InterventionAncestorId"=>"D000020011", "InterventionAncestorTerm"=>"Protective Agents"}, {"InterventionAncestorId"=>"D000014803", "InterventionAncestorTerm"=>"Vitamin B Complex"}, {"InterventionAncestorId"=>"D000014815", "InterventionAncestorTerm"=>"Vitamins"}, {"InterventionAncestorId"=>"D000018977", "InterventionAncestorTerm"=>"Micronutrients"}, {"InterventionAncestorId"=>"D000000935", "InterventionAncestorTerm"=>"Antifungal Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000964", "InterventionAncestorTerm"=>"Antimetabolites, Antineoplastic"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000005493", "InterventionAncestorTerm"=>"Folic Acid Antagonists"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5398", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6191", "InterventionBrowseLeafName"=>"Leucovorin", "InterventionBrowseLeafAsFound"=>"Sodium", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5381", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafAsFound"=>"Double-blind", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M29233", "InterventionBrowseLeafName"=>"Levoleucovorin", "InterventionBrowseLeafAsFound"=>"Exercise training", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17546", "InterventionBrowseLeafName"=>"Vitamin B Complex", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8618", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8619", "InterventionBrowseLeafName"=>"Folic Acid Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M18981", "InterventionBrowseLeafName"=>"Trimetrexate", "InterventionBrowseLeafAsFound"=>"Outdoors", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4250", "InterventionBrowseLeafName"=>"Antidotes", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21869", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17558", "InterventionBrowseLeafName"=>"Vitamins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21009", "InterventionBrowseLeafName"=>"Micronutrients", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16885", "InterventionBrowseLeafName"=>"Trace Elements", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6252", "InterventionBrowseLeafName"=>"Clotrimazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11796", "InterventionBrowseLeafName"=>"Miconazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4254", "InterventionBrowseLeafName"=>"Antifungal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4281", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T447", "InterventionBrowseLeafName"=>"Folinic Acid", "InterventionBrowseLeafAsFound"=>"Exercise training", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T446", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T448", "InterventionBrowseLeafName"=>"Folate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T475", "InterventionBrowseLeafName"=>"Vitamin B9", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"50"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"April 1989", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 28, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 4, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Trimetrexate", "AIDS-Related Opportunistic Infections", "Pneumonia, Pneumocystis carinii", "Injections, Intravenous", "Leucovorin", "Dose-Response Relationship, Drug", "Drug Therapy, Combination", "Folic Acid Antagonists", "Administration, Oral", "Acquired Immunodeficiency Syndrome", "Antineoplastic Agents"]}, "ConditionList"=>{"Condition"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"2136905", "ReferenceType"=>"background", "ReferenceCitation"=>"Sattler FR, Allegra CJ, Verdegem TD, Akil B, Tuazon CU, Hughlett C, Ogata-Arakaki D, Feinberg J, Shelhamer J, Lane HC, et al. Trimetrexate-leucovorin dosage evaluation study for treatment of Pneumocystis carinii pneumonia. J Infect Dis. 1990 Jan;161(1):91-6. doi: 10.1093/infdis/161.1.91."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.", "DetailedDescription"=>"TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.\n\nIncreasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50 AIDS patients. Doses are increased for 21 days on a once daily and then a twice daily basis. Dose escalations occur in subsequent groups of patients."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"60 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nPatient must:\n\nHave Pneumocystis carinii pneumonia (PCP) that has not been treated for current episode. PCP must be documented by observation of > 1 cluster of organisms in sputum, bronchial secretion, or lung tissue.\nHave clinical symptoms of respiratory disease or radiologic abnormalities.\n\nExclusion Criteria\n\nPatient cannot have significant emotional disorder.\n\nConcurrent Medication: Excluded:\n\nDrugs likely to be bone marrow toxic.\nInvestigational drugs.\n\nPrior Medication: Excluded:\n\nThree patients in each group cannot have had zidovudine (AZT) for at least 2 months prior to administration of trimetrexate."}, "IdentificationModule"=>{"NCTId"=>"NCT00000998", "BriefTitle"=>"A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Evaluation of Escalating Doses of Intravenous Trimetrexate as Therapy for Previously Untreated Pneumocystis Carinii Pneumonia in AIDS Patients With Subsequent Comparison of Intravenous and Oral Pharmacokinetics", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 018"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"10994", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Trimetrexate glucuronate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Leucovorin calcium", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Los Angeles County - USC Med Ctr"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Masur H", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
