Nctid:
NCT00002192
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "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"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18877", "name"=>"Bacteremia", "asFound"=>"Bacteremia", "relevance"=>"HIGH"}, {"id"=>"M12119", "name"=>"Mycobacterium Infections", "asFound"=>"Mycobacterium", "relevance"=>"HIGH"}, {"id"=>"M17970", "name"=>"Mycobacterium avium-intracellulare Infection", "asFound"=>"Mycobacterium avium-intracellulare Infection", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"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"=>"M16355", "name"=>"Syndrome", "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"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017963", "term"=>"Azithromycin"}, {"id"=>"D017291", "term"=>"Clarithromycin"}, {"id"=>"D004977", "term"=>"Ethambutol"}, {"id"=>"C018421", "term"=>"Rifapentine"}], "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"=>"D000904", "term"=>"Antibiotics, Antitubercular"}, {"id"=>"D007917", "term"=>"Leprostatic Agents"}], "browseLeaves"=>[{"id"=>"M19585", "name"=>"Clarithromycin", "asFound"=>"Like", "relevance"=>"HIGH"}, {"id"=>"M8125", "name"=>"Ethambutol", "asFound"=>"Obesity Management", "relevance"=>"HIGH"}, {"id"=>"M20132", "name"=>"Azithromycin", "asFound"=>"Basis", "relevance"=>"HIGH"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M236319", "name"=>"Rifapentine", "asFound"=>"Stopping", "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"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1997-08", "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"=>["AIDS-Related Opportunistic Infections", "Mycobacterium avium-intracellulare Infection", "Drug Therapy, Combination", "Antitubercular Agents", "Azithromycin", "Clarithromycin", "Bacteremia", "rifapentine"], "conditions"=>["Mycobacterium Avium-Intracellulare Infection", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.", "detailedDescription"=>"This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase.\n\nIn the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy.\n\nIn the combination treatment phase, 12 patients each are randomized to one of three arms:\n\nArm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin.\n\nArm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Documented positive HIV serology status.\n* Documented AIDS.\n* Positive blood culture for MAC from the study-designated microbiology laboratory. NOTE:\n* Patients with presumed MAC bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation.\n* Minimum of two MAC-associated symptoms, defined as \\>= grade 1 fever; \\> grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss \\> 5% reported within 4 weeks prior to study entry.\n* Life expectancy of at least 3 months.\n\nPrior Medication:\n\nAllowed:\n\nMAC prophylaxis with medications other than study drugs (5-day washout period required).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Pulmonary tuberculosis.\n* Infections requiring the use of disallowed medications.\n* Serious diseases that introduce undue risks for adverse reactions to study medication.\n\nConcurrent Medication:\n\nExcluded:\n\n* Terfenadine.\n* Treatment for pulmonary TB.\n* Study drugs from an outside source.\n* Medications with anti-MAC activity (i.e., amikacin, ciprofloxacin, clofazimine, rifampin, and rifabutin).\n\nPatients with the following prior conditions are excluded:\n\n* History of hypersensitivity to rifabutin, rifampin, clarithromycin, erythromycin, azithromycin, or ethambutol.\n* Previous episode of uveitis.\n\nPrior Medication:\n\nExcluded:\n\n* Prophylactic treatment for MAC with rifabutin or any of the study medications.\n* Azithromycin within the 3 weeks prior to randomization.\n* Any investigational drug during the 4 weeks prior to randomization."}, "identificationModule"=>{"nctId"=>"NCT00002192", "briefTitle"=>"Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.", "orgStudyIdInfo"=>{"id"=>"275A"}, "secondaryIdInfos"=>[{"id"=>"000473PR0018"}, {"id"=>"96ACR-HMD1"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Rifapentine", "type"=>"DRUG"}, {"name"=>"Ethambutol hydrochloride", "type"=>"DRUG"}, {"name"=>"Clarithromycin", "type"=>"DRUG"}, {"name"=>"Azithromycin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"23666", "city"=>"Hampton", "state"=>"Virginia", "country"=>"United States", "facility"=>"Hampton Roads Med Specialists", "geoPoint"=>{"lat"=>37.02987, "lon"=>-76.34522}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Anderson Clinical Research", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Hoechst Marion Roussel", "class"=>"INDUSTRY"}]}}}
