Nctid:
NCT00002331
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D015270", "term"=>"Mycobacterium avium-intracellulare Infection"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D001424", "term"=>"Bacterial Infections"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D009165", "term"=>"Mycobacterium Infections, Nontuberculous"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12119", "name"=>"Mycobacterium Infections", "asFound"=>"Mycobacterium", "relevance"=>"HIGH"}, {"id"=>"M17970", "name"=>"Mycobacterium avium-intracellulare Infection", "asFound"=>"Mycobacterium Avium", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M12120", "name"=>"Mycobacterium Infections, Nontuberculous", "relevance"=>"LOW"}, {"id"=>"T3977", "name"=>"Mycobacterium Avium Complex Infections", "asFound"=>"Mycobacterium Avium", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017291", "term"=>"Clarithromycin"}, {"id"=>"D004977", "term"=>"Ethambutol"}, {"id"=>"D002991", "term"=>"Clofazimine"}], "ancestors"=>[{"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D011500", "term"=>"Protein Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000995", "term"=>"Antitubercular Agents"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D007917", "term"=>"Leprostatic Agents"}], "browseLeaves"=>[{"id"=>"M6224", "name"=>"Clofazimine", "asFound"=>"Singing", "relevance"=>"HIGH"}, {"id"=>"M19585", "name"=>"Clarithromycin", "asFound"=>"Pharmacodynamics", "relevance"=>"HIGH"}, {"id"=>"M8125", "name"=>"Ethambutol", "asFound"=>"Anastrozole 1 mg", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2009-02", "completionDateStruct"=>{"date"=>"1995-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-01-15", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2015-01-16", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1995-03", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Mycobacterium avium-intracellular Infection", "Drug Therapy, Combination", "Ethambutol", "Clofazimine", "Acquired Immunodeficiency Syndrome", "Clarithromycin"], "conditions"=>["Mycobacterium Avium-intracellular Infection", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9147422", "type"=>"BACKGROUND", "citation"=>"Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008."}]}, "descriptionModule"=>{"briefSummary"=>"PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).\n\nSECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* History of HIV seropositivity.\n* Disseminated MAC.\n* Positive blood culture for MAC within 4 weeks prior to study entry.\n* Consent of parent or guardian if less than 18 years of age.\n* Ability to complete the study.\n\nNOTE:\n\n* Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.\n* Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.\n* Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).\n* Amikacin.\n* Azithromycin.\n* Capreomycin.\n* Ciprofloxacin.\n* Cycloserine.\n* Ethionamide.\n* Gentamicin.\n* Kanamycin.\n* Levofloxacin.\n* Lomefloxacin.\n* Ofloxacin.\n* Rifampin.\n* Rifabutin.\n* Sparfloxacin.\n* Streptomycin.\n* Any other aminoglycosides, quinolones, and macrolides.\n\nPatients with the following prior conditions are excluded:\n\nHistory of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.\n\nPrior Medication:\n\nExcluded:\n\n* Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.\n* Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months."}, "identificationModule"=>{"nctId"=>"NCT00002331", "briefTitle"=>"The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Abbott"}, "officialTitle"=>"A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS", "orgStudyIdInfo"=>{"id"=>"214A"}, "secondaryIdInfos"=>[{"id"=>"M93-069"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ethambutol hydrochloride", "type"=>"DRUG"}, {"name"=>"Clarithromycin", "type"=>"DRUG"}, {"name"=>"Clofazimine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"95817", "city"=>"Sacramento", "state"=>"California", "country"=>"United States", "facility"=>"UCD Med Ctr", "geoPoint"=>{"lat"=>38.58157, "lon"=>-121.4944}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"951282699", "city"=>"San Jose", "state"=>"California", "country"=>"United States", "facility"=>"Santa Clara Valley Med Ctr", "geoPoint"=>{"lat"=>37.33939, "lon"=>-121.89496}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Dr Margaret Fischel", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33614", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Saint Joseph's Hosp / Infectious Disease Rsch Institute", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - Saint Luke's Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"701122699", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ Med School", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Univ School of Medicine", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina School of Medicine", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Dr Stephen Hauptman", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"37212", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Univ School of Medicine", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"00907", "city"=>"Condado San Juan", "country"=>"Puerto Rico", "facility"=>"Dr Javier Morales"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Abbott", "class"=>"INDUSTRY"}}}}
