Nctid:
NCT00000863
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000015658", "term"=>"HIV Infections"}, {"id"=>"D000000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D000011020", "term"=>"Pneumonia, Pneumocystis"}], "ancestors"=>[{"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000012897", "term"=>"Slow Virus 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"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "asFound"=>"Pneumonia", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M13910", "name"=>"Pneumonia, Pneumocystis", "asFound"=>"Pneumonia, Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "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"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus 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"=>"Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"T4599", "name"=>"Pneumocystosis", "asFound"=>"Pneumocystis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>45}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-07", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["AIDS-Related Opportunistic Infections", "Pneumonia, Pneumocystis carinii", "Administration, Oral", "WR 6026"], "conditions"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"10235511", "type"=>"BACKGROUND", "citation"=>"Petty BG, Black JR, Hendrix CW, Lewis LD, Basiakos Y, Feinberg J, Pattison DG, Hafner R. Escalating multiple-dose safety and tolerance study of oral WR 6026 in HIV-infected subjects: AIDS clinical trials group 173. J Acquir Immune Defic Syndr. 1999 May 1;21(1):26-32. doi: 10.1097/00126334-199905010-00004."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026 concentrations and outcome/toxicity.", "detailedDescription"=>"All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Any medications not listed as excluded will be permitted on study.\n\n\\[ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.\\]\n\nPatients must have:\n\n* Documented HIV infection.\n* Documented PCP.\n* On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg.\n* Signed informed consent from parent or legal guardian for those patients less than 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Known hypersensitivity to quinolines.\n* If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine).\n* Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites).\n\nPatients with the following prior conditions or symptoms are excluded:\n\n* History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency.\n\nPrior Medication:\n\nExcluded:\n\n* More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at study entry."}, "identificationModule"=>{"nctId"=>"NCT00000863", "briefTitle"=>"A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II Study of WR 6026 for Pneumocystis Carinii Pneumonia in People With HIV Infection", "orgStudyIdInfo"=>{"id"=>"ACTG 314"}, "secondaryIdInfos"=>[{"id"=>"11289", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Sitamaquine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Alabama Therapeutics CRS", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Queens Med. Ctr.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Univ. of Hawaii at Manoa, Leahi Hosp.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60640", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Weiss Memorial Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Wishard Memorial", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Methodist Hosp. of Indiana", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY - Buffalo, Erie County Medical Ctr.", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NY Univ. HIV/AIDS CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"45267", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ. of Cincinnati CRS", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"The Ohio State Univ. AIDS CRS", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}], "overallOfficials"=>[{"name"=>"Dohn M", "role"=>"STUDY_CHAIR"}, {"name"=>"Petty B", "role"=>"STUDY_CHAIR"}, {"name"=>"Black J", "role"=>"STUDY_CHAIR"}, {"name"=>"Frame P", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
