Nctid:
NCT00000715
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011014", "term"=>"Pneumonia"}, {"id"=>"D011020", "term"=>"Pneumonia, Pneumocystis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D008172", "term"=>"Lung Diseases, Fungal"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D016720", "term"=>"Pneumocystis Infections"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "asFound"=>"Pneumonia", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M27137", "name"=>"Respiratory Aspiration", "relevance"=>"LOW"}, {"id"=>"M13910", "name"=>"Pneumonia, Pneumocystis", "asFound"=>"Pneumonia, Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "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"=>"Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"T4599", "name"=>"Pneumocystosis", "asFound"=>"Pneumocystis", "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"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D014295", "term"=>"Trimethoprim"}, {"id"=>"D015662", "term"=>"Trimethoprim, Sulfamethoxazole Drug Combination"}, {"id"=>"D013420", "term"=>"Sulfamethoxazole"}, {"id"=>"D010419", "term"=>"Pentamidine"}], "ancestors"=>[{"id"=>"D000892", "term"=>"Anti-Infective Agents, Urinary"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000962", "term"=>"Antimalarials"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018726", "term"=>"Anti-Dyskinesia Agents"}, {"id"=>"D065687", "term"=>"Cytochrome P-450 CYP2C8 Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D014344", "term"=>"Trypanocidal Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}], "browseLeaves"=>[{"id"=>"M18253", "name"=>"Trimethoprim, Sulfamethoxazole Drug Combination", "asFound"=>"Stage IV chronic lymphocytic leukemia", "relevance"=>"HIGH"}, {"id"=>"M17047", "name"=>"Trimethoprim", "asFound"=>"Bacteria", "relevance"=>"HIGH"}, {"id"=>"M16206", "name"=>"Sulfamethoxazole", "asFound"=>"350", "relevance"=>"HIGH"}, {"id"=>"M13330", "name"=>"Pentamidine", "asFound"=>"Drainage tube", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4280", "name"=>"Antimalarials", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>240}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1991-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Trimethoprim-Sulfamethoxazole Combination", "AIDS-Related Opportunistic Infections", "Pneumonia, Pneumocystis carinii", "Pentamidine", "Infusions, Intravenous", "Administration, Inhalation", "Aerosols", "Acquired Immunodeficiency Syndrome", "Sulfamethoxazole-Trimethoprim"], "conditions"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7697233", "type"=>"BACKGROUND", "citation"=>"Montgomery AB, Feigal DW Jr, Sattler F, Mason GR, Catanzaro A, Edison R, Markowitz N, Johnson E, Ogawa S, Rovzar M, et al. Pentamidine aerosol versus trimethoprim-sulfamethoxazole for Pneumocystis carinii in acquired immune deficiency syndrome. Am J Respir Crit Care Med. 1995 Apr;151(4):1068-74. doi: 10.1164/ajrccm/151.4.1068."}]}, "descriptionModule"=>{"briefSummary"=>"To compare the safety and effectiveness of drug therapy with aerosolized pentamidine (PEN) with that of conventional therapy, sulfamethoxazole plus trimethoprim (SMX/TMP) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection.\n\nNew treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects.", "detailedDescription"=>"New treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects.\n\nPatients entered in the study are randomly assigned to aerosolized PEN or to intravenous SMX/TMP, for a 21-day trial. SMX/TMP is given 4 times a day and aerosolized PEN once a day. Doses are determined by body size. Patients who receive aerosolized PEN also receive a placebo intravenous injection and patients who receive SMX/TMP also receive a placebo aerosol. Patients are hospitalized at least 5 days. Patients who improve may be discharged after 5 days at the discretion of the attending physician. Discharged patients continue the study with oral SMX/TMP and aerosolized placebo or aerosolized PEN and oral placebo. Patients who fail to respond or who develop severe adverse effects are switched to intravenous PEN or other standard therapy. During the 21-day trial, zidovudine (AZT) may not be used. AZT may be resumed after therapy for the acute PCP episode is completed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPrior Medication:\n\nAllowed:\n\n* Zidovudine (AZT), but must be suspended during study medication.\n\nUnequivocal diagnosis of Pneumocystis carinii pneumonia established by morphologic confirmation of three or more typical Pneumocystis carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 5 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 less than 30 torr on room air at all ACTG sites except San Francisco General Hospital. Non-ACTG sites will enter patients up to a resting (A-a) DO2less than 55 mmHg on room air.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration.\n* History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as:\n* Absolute neutropenia of 750 or less PMN + bands cells/mm3.\n* Thrombocytopenia below 40000 platelets/mm3.\n* Rise in creatinine:\n* To more than 3.0 mg/dl.\n* Liver function abnormalities:\n* SGOT or SGPT greater than 5 x upper limit of normal.\n* Hypoglycemia below 50 mg/dl.\n* Rash:\n* Exfoliative or mucositis.\n* Cough:\n* Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia.\n* Zidovudine (AZT).\n\nPatients with the following are excluded:\n\n* Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration.\n* History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as:\n* Absolute neutropenia of 750 or less PMN + bands cells/mm3.\n* Thrombocytopenia lower than 40000 platelets/mm3.\n* Rise in creatinine:\n* To greater than 3.0 mg/dl.\n* Liver function abnormalities:\n* SGOT or SGPT greater than 5 x upper limit of normal.\n* Hypoglycemia less than 50 mg/dl.\n* Rash:\n* Exfoliative or mucositis.\n* Cough:\n* Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days.\n\nPrior Medication:\n\nExcluded within 14 days of study entry:\n\n* Systemic steroids higher than adrenal replacement doses.\n* Excluded within 6 weeks of study entry:\n* Another antiprotozoal regimen for this episode, whether therapeutic or prophylactic.\n* Sulfamethoxazole / trimethoprim.\n* Pyrimethamine.\n* Sulfadoxine / pyrimethamine.\n* Pentamidine.\n* Eflornithine."}, "identificationModule"=>{"nctId"=>"NCT00000715", "briefTitle"=>"A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia in AIDS", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Pneumonia in AIDS", "orgStudyIdInfo"=>{"id"=>"ACTG 040"}, "secondaryIdInfos"=>[{"id"=>"11015", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Pentamidine isethionate", "type"=>"DRUG"}, {"name"=>"Sulfamethoxazole-Trimethoprim", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ School of Medicine", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Harvard (Massachusetts Gen Hosp)", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"10461", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Municipal Hosp Ctr/Jacobi Med Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Medical Center", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"452670405", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Holmes Hosp / Univ of Cincinnati Med Ctr", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ Hosp of Cleveland / Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"29169", "city"=>"West Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Julio Arroyo", "geoPoint"=>{"lat"=>33.99349, "lon"=>-81.07398}}], "overallOfficials"=>[{"name"=>"B Montgomery", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
