Nctid:
NCT00001027
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000011020", "term"=>"Pneumonia, Pneumocystis"}], "ancestors"=>[{"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000008172", "term"=>"Lung Diseases, Fungal"}, {"id"=>"D000009181", "term"=>"Mycoses"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D000016720", "term"=>"Pneumocystis Infections"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "asFound"=>"Pneumonia", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M13910", "name"=>"Pneumonia, Pneumocystis", "asFound"=>"Pneumonia, Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11169", "name"=>"Lung Diseases, Fungal", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M19082", "name"=>"Pneumocystis Infections", "relevance"=>"LOW"}, {"id"=>"T4598", "name"=>"Pneumocystis Jirovecii Pneumonia", "asFound"=>"Pneumonia, Pneumocystis carinii", "relevance"=>"HIGH"}, {"id"=>"T4599", "name"=>"Pneumocystosis", "asFound"=>"Pneumonia, Pneumocystis carinii", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000010419", "term"=>"Pentamidine"}], "ancestors"=>[{"id"=>"D000000935", "term"=>"Antifungal Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000014344", "term"=>"Trypanocidal Agents"}], "browseLeaves"=>[{"id"=>"M13330", "name"=>"Pentamidine", "asFound"=>"Developmental Delay", "relevance"=>"HIGH"}, {"id"=>"M17047", "name"=>"Trimethoprim", "relevance"=>"LOW"}, {"id"=>"M16206", "name"=>"Sulfamethoxazole", "relevance"=>"LOW"}, {"id"=>"M18253", "name"=>"Trimethoprim, Sulfamethoxazole Drug Combination", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>32}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1996-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Pneumonia, Pneumocystis carinii", "Pentamidine", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"], "conditions"=>["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"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"6 years", "minimumAge"=>"1 month", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Steroids and intravenous immune globulin (IVIG).\n\nPatients must have:\n\n* Documented HIV infection.\n* Need for PCP prophylaxis.\n* Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).\n\nOne of the following required conditions:\n\n* Known 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\n* Co-enrollment in other ACTG pediatric studies is permitted.\n\nConsent of parent or guardian is required.\n\nPrior Medication:\n\nAllowed:\n\n* Prior pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Active PCP.\n* Pancreatitis defined as amylase elevation associated with an elevated lipase that is \\> 2 x upper limit of normal.\n\nPrior Medication:\n\nExcluded:\n\n* TMP-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"=>{"class"=>"NIH", "fullName"=>"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"=>{"id"=>"ACTG 189"}, "secondaryIdInfos"=>[{"id"=>"11164", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Pentamidine isethionate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Usc La Nichd Crs", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"20010", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Children's National Med. Ctr., ACTU", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20060", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Howard Univ. Washington DC NICHD CRS", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"60614", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60637", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane/LSU Maternal/Child CRS", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NYU Med. Ctr., Dept. of Medicine", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp. Ctr. NY NICHD CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Upstate Med. Univ., Dept. of Peds", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"00936", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Van Dyke R", "role"=>"STUDY_CHAIR"}, {"name"=>"Pramberg J", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Fujisawa Pharmaceutical Co", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
