Nctid:
NCT00002343
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D016470", "term"=>"Bacteremia"}, {"id"=>"D009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D015270", "term"=>"Mycobacterium avium-intracellulare Infection"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D001424", "term"=>"Bacterial Infections"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D018805", "term"=>"Sepsis"}, {"id"=>"D018746", "term"=>"Systemic Inflammatory Response Syndrome"}, {"id"=>"D007249", "term"=>"Inflammation"}, {"id"=>"D000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D009165", "term"=>"Mycobacterium Infections, Nontuberculous"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M18877", "name"=>"Bacteremia", "asFound"=>"Bacteremia", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M12119", "name"=>"Mycobacterium Infections", "asFound"=>"Mycobacterium", "relevance"=>"HIGH"}, {"id"=>"M17970", "name"=>"Mycobacterium avium-intracellulare Infection", "asFound"=>"Mycobacterium avium-intracellulare Infection", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M20864", "name"=>"Sepsis", "relevance"=>"LOW"}, {"id"=>"M16869", "name"=>"Toxemia", "relevance"=>"LOW"}, {"id"=>"M20818", "name"=>"Systemic Inflammatory Response Syndrome", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12120", "name"=>"Mycobacterium Infections, Nontuberculous", "relevance"=>"LOW"}, {"id"=>"T3977", "name"=>"Mycobacterium Avium Complex Infections", "asFound"=>"Mycobacterium Avium", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D004977", "term"=>"Ethambutol"}, {"id"=>"D017828", "term"=>"Rifabutin"}], "ancestors"=>[{"id"=>"D000995", "term"=>"Antitubercular Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000904", "term"=>"Antibiotics, Antitubercular"}], "browseLeaves"=>[{"id"=>"M8125", "name"=>"Ethambutol", "asFound"=>"Rewarding", "relevance"=>"HIGH"}, {"id"=>"M20019", "name"=>"Rifabutin", "asFound"=>"Brackets", "relevance"=>"HIGH"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1997-06", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Rifabutin", "Mycobacterium avium-intracellulare Infection", "Drug Therapy, Combination", "Ethambutol", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Mycobacterium Avium-Intracellulare Infection", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.", "detailedDescription"=>"Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* AZT, d4T, ddI, or ddC.\n* Antipneumocystis prophylaxis.\n\nAllowed:\n\n* Short course (\\< 14 days) of ciprofloxacin for acute infections.\n\nPatients must have:\n\n* AIDS.\n* CD4 count \\<= 100 cells/mm3.\n* NO prior or current MAC infection.\n\nPrior Medication:\n\nRequired:\n\n* Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.\n\nAllowed:\n\n* Prior rifabutin.\n* Prior ethambutol.\n* Prior clarithromycin.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Positive tuberculin skin test (PPD \\> 5 mm).\n* Active M. tuberculosis.\n* Perceived as unreliable or unavailable for frequent monitoring.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other antiretrovirals not specifically allowed.\n* All investigational drugs.\n* Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (\\>= 14 days).\n\nPatients with the following prior conditions are excluded:\n\nKnown hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.\n\nPrior Medication:\n\nExcluded within 4 weeks prior to study entry:\n\n* Rifampin.\n* Isoniazid.\n* Clofazimine.\n* Cycloserine.\n* Ethionamide.\n* Amikacin.\n* Ciprofloxacin."}, "identificationModule"=>{"nctId"=>"NCT00002343", "briefTitle"=>"A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3", "orgStudyIdInfo"=>{"id"=>"048E"}, "secondaryIdInfos"=>[{"id"=>"CS 087287-000"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ethambutol hydrochloride", "type"=>"DRUG"}, {"name"=>"Rifabutin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"95817", "city"=>"Sacramento", "state"=>"California", "country"=>"United States", "facility"=>"Univ of California - Davis Med Ctr / CARES", "geoPoint"=>{"lat"=>38.58157, "lon"=>-121.4944}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pharmacia", "class"=>"INDUSTRY"}}}}
