Nctid:
NCT00001027
Payload:
{"FullStudy"=>{"Rank"=>474587, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000011014", "ConditionMeshTerm"=>"Pneumonia"}, {"ConditionMeshId"=>"D000011020", "ConditionMeshTerm"=>"Pneumonia, Pneumocystis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000012141", "ConditionAncestorTerm"=>"Respiratory Tract Infections"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"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"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13594", "ConditionBrowseLeafName"=>"Pneumonia", "ConditionBrowseLeafAsFound"=>"Pneumonia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13600", "ConditionBrowseLeafName"=>"Pneumonia, Pneumocystis", "ConditionBrowseLeafAsFound"=>"Pneumonia, Pneumocystis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3425", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14668", "ConditionBrowseLeafName"=>"Respiratory Tract Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10858", "ConditionBrowseLeafName"=>"Lung Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14667", "ConditionBrowseLeafName"=>"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10859", "ConditionBrowseLeafName"=>"Lung Diseases, Fungal", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11826", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4412", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4411", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18772", "ConditionBrowseLeafName"=>"Pneumocystis Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T4598", "ConditionBrowseLeafName"=>"Pneumocystis Jirovecii Pneumonia", "ConditionBrowseLeafAsFound"=>"Pneumonia, Pneumocystis carinii", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4599", "ConditionBrowseLeafName"=>"Pneumocystosis", "ConditionBrowseLeafAsFound"=>"Pneumonia, Pneumocystis carinii", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000010419", "InterventionMeshTerm"=>"Pentamidine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000935", "InterventionAncestorTerm"=>"Antifungal Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}, {"InterventionAncestorId"=>"D000014344", "InterventionAncestorTerm"=>"Trypanocidal Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M17943", "InterventionBrowseLeafName"=>"Trimethoprim, Sulfamethoxazole Drug Combination", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16737", "InterventionBrowseLeafName"=>"Trimethoprim", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15896", "InterventionBrowseLeafName"=>"Sulfamethoxazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M13020", "InterventionBrowseLeafName"=>"Pentamidine", "InterventionBrowseLeafAsFound"=>"Telemetry", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3944", "InterventionBrowseLeafName"=>"Antifungal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5942", "InterventionBrowseLeafName"=>"Clotrimazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11486", "InterventionBrowseLeafName"=>"Miconazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3988", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3984", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Dyskinesia Agents", "InterventionBrowseBranchAbbrev"=>"AnDyAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"32"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"September 1996", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 28, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 1, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Pneumonia, Pneumocystis carinii", "Pentamidine", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"]}, "ConditionList"=>{"Condition"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}}, "DescriptionModule"=>{"BriefSummary"=>"Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population.\n\nSecondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis.\n\nProphylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.", "DetailedDescription"=>"Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.\n\nThirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age < 24 months or age >= 24 months. Steady-state pharmacokinetics will be examined in a subsample of 20 patients."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"6 years", "MinimumAge"=>"1 month", "StdAgeList"=>{"StdAge"=>["Child"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nSteroids and intravenous immune globulin (IVIG).\n\nPatients must have:\n\nDocumented HIV infection.\nNeed for PCP prophylaxis.\nKnown intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).\n\nOne of the following required conditions:\n\nKnown intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179.\n\nNOTE:\n\nCo-enrollment in other ACTG pediatric studies is permitted.\n\nConsent of parent or guardian is required.\n\nPrior Medication:\n\nAllowed:\n\nPrior pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\nActive PCP.\nPancreatitis defined as amylase elevation associated with an elevated lipase that is > 2 x upper limit of normal.\n\nPrior Medication:\n\nExcluded:\n\nTMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving)."}, "IdentificationModule"=>{"NCTId"=>"NCT00001027", "BriefTitle"=>"A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 189"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11164", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Pentamidine isethionate", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Usc La Nichd Crs"}, {"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS"}, {"LocationCity"=>"Oakland", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab."}, {"LocationZip"=>"20010", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Children's National Med. Ctr., ACTU"}, {"LocationZip"=>"20060", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Howard Univ. Washington DC NICHD CRS"}, {"LocationZip"=>"60614", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Chicago Children's CRS"}, {"LocationZip"=>"60637", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease"}, {"LocationZip"=>"70112", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane/LSU Maternal/Child CRS"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"NYU Med. Ctr., Dept. of Medicine"}, {"LocationZip"=>"10037", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Harlem Hosp. Ctr. NY NICHD CRS"}, {"LocationCity"=>"Syracuse", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY Upstate Med. Univ., Dept. of Peds"}, {"LocationZip"=>"00936", "LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"San Juan City Hosp. PR NICHD CRS"}, {"LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Van Dyke R", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Pramberg J", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Fujisawa Pharmaceutical Co", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
