Nctid:
NCT00002122
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D015270", "term"=>"Mycobacterium avium-intracellulare Infection"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D001424", "term"=>"Bacterial Infections"}, {"id"=>"D009165", "term"=>"Mycobacterium Infections, Nontuberculous"}], "browseLeaves"=>[{"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "asFound"=>"Mycosis", "relevance"=>"HIGH"}, {"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-intracellulare Infection", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "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"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017963", "term"=>"Azithromycin"}, {"id"=>"D017828", "term"=>"Rifabutin"}, {"id"=>"D015725", "term"=>"Fluconazole"}], "ancestors"=>[{"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D006727", "term"=>"Hormone Antagonists"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"id"=>"D000904", "term"=>"Antibiotics, Antitubercular"}, {"id"=>"D000995", "term"=>"Antitubercular Agents"}], "browseLeaves"=>[{"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"Upper extremity", "relevance"=>"HIGH"}, {"id"=>"M20132", "name"=>"Azithromycin", "asFound"=>"Observational Study", "relevance"=>"HIGH"}, {"id"=>"M20019", "name"=>"Rifabutin", "asFound"=>"Consent form", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>720}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-04", "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", "Mycoses", "Drug Therapy, Combination", "Fluconazole", "Acquired Immunodeficiency Syndrome", "Azithromycin"], "conditions"=>["Mycoses", "Mycobacterium Avium-Intracellulare Infection", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Havlir DV, Mccutchan JA, Bozzette SA, Dunne M. A double-blind, randomized study of weekly azithromycin, daily rifabutin, and combination azithromycin and rifabutin for the prevention of Mycobactetum avium complex (MAC) in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90"}]}, "descriptionModule"=>{"briefSummary"=>"PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population.\n\nSECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.", "detailedDescription"=>"Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Preventive therapy with isoniazid for M. tuberculosis.\n* Maintenance therapy for CMV retinitis.\n\nPatients must have:\n\n* HIV infection or history of an AIDS-defining condition by CDC criteria.\n* One documented CD4 count \\< 100 cells/mm3 within 12 months prior to study entry.\n* NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous).\n* NO acute opportunistic infection.\n* Life expectancy of more than 6 months.\n* Consent of parent or guardian if less than legal age of consent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nALL PATIENTS -\n\n* Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded.\n* Serious hypersensitivity reactions to macrolides or rifampin.\n* Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION -\n* Serious hypersensitivity reaction to fluconazole.\n* Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis).\n* Positive baseline urine cryptococcal culture.\n\nConcurrent Medication:\n\nExcluded for fluconazole randomization:\n\n* Maintenance therapy for deep fungal infections.\n* Chronic therapy with ketoconazole or fluconazole."}, "identificationModule"=>{"nctId"=>"NCT00002122", "briefTitle"=>"A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"226A"}, "secondaryIdInfos"=>[{"id"=>"066-174"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Azithromycin", "type"=>"DRUG"}, {"name"=>"Rifabutin", "type"=>"DRUG"}, {"name"=>"Fluconazole", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92668", "city"=>"Orange", "state"=>"California", "country"=>"United States", "facility"=>"UCI Med Ctr", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Treatment Ctr / Dept of Medicine and Pediatrics", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"951282699", "city"=>"San Jose", "state"=>"California", "country"=>"United States", "facility"=>"Santa Clara Valley Med Ctr", "geoPoint"=>{"lat"=>37.33939, "lon"=>-121.89496}}, {"zip"=>"90509", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"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"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Univ of Massachusetts Med Ctr", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77005", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pfizer", "class"=>"INDUSTRY"}}}}
