Nctid:
NCT00001039
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-intracellulare Infection", "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-intracellulare Infection", "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"}], "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"}], "browseLeaves"=>[{"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"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>24}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-10", "completionDateStruct"=>{"date"=>"2002-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-10-29", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2012-10-31", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Mycobacterium avium-intracellulare Infection", "Drug Therapy, Combination", "Ethambutol", "Acquired Immunodeficiency Syndrome", "Clarithromycin"], "conditions"=>["Mycobacterium Avium-intracellulare Infection", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To assess the feasibility of using culture and staining techniques to quantify tissue Mycobacterium avium Complex (MAC) burden in bone marrow. To correlate and compare changes in MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4 and 8 weeks of treatment.\n\nMAC is easiest to detect in the blood, although doctors generally believe that MAC in blood is just \"spill-over\" from infection of other parts of the body. Traditionally, studies of potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC changes in blood to those in bone marrow, which is another tissue where MAC is often found.", "detailedDescription"=>"MAC is easiest to detect in the blood, although doctors generally believe that MAC in blood is just \"spill-over\" from infection of other parts of the body. Traditionally, studies of potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC changes in blood to those in bone marrow, which is another tissue where MAC is often found.\n\nPatients receive both clarithromycin and ethambutol for 48 weeks; those who become intolerant to the study drugs may receive suggested substitute drugs (azithromycin and rifabutin). Patients receive a bone marrow biopsy at baseline and at either 4 or 8 weeks. Patients are evaluated at weeks 1, 2, 4, 6, 8, 12, 24, 36, and 48."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Any antiretroviral therapy that is approved or is available through an FDA-sanctioned treatment IND or treatment protocol.\n* Primary or secondary PCP prophylaxis with TMP/SMX, dapsone, or aerosolized pentamidine, as well as approved therapies for other AIDS-related opportunistic infections not otherwise excluded.\n* Erythromycin, interferon-alpha, and supportive care for any therapy-related toxicities as necessary.\n\nPatients must have:\n\n* HIV infection.\n* Confirmed MAC bacteremia.\n* Consent of parent or guardian if less than 18 years of age.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* MAC inhibitors, including aminoglycosides, quinolones, clofazimine, azithromycin (except when administered as a substitute drug), and rifamycins, during the first 24 weeks of the study.\n* Immunomodulators (including colony-stimulating cytokines such as GM-CSF and G-CSF) other than those that are specifically allowed.\n* Steroids in excess of physiologic replacement doses.\n* Cytotoxic chemotherapy.\n\nPatients with the following prior conditions are excluded:\n\n* History of treatment-limiting intolerance or hypersensitivity to the study drugs or other macrolides.\n* Changes on chest radiograph within 7 days prior to study entry, that are consistent with acute Pneumocystis carinii pneumonia, pulmonary tuberculosis, or other acute respiratory infection.\n\nPrior Medication:\n\nExcluded:\n\n* Clarithromycin, azithromycin, or ethambutol for more than 10 consecutive days within the 8 weeks prior to study entry OR between the time an initial AFB positive blood sample was collected and study entry.\n* Cytokines (other than erythropoietin and interferon-alpha) within 8 weeks prior to study entry.\n* Steroids within 8 weeks prior to study entry.\n* Cytotoxic chemotherapy within 8 weeks prior to study entry.\n* Acute therapy for an AIDS-related opportunistic infection or malignancy, or other acute medical illness or infection within 4 weeks prior to study entry.\n* Rifabutin monotherapy if initiated for MAC prophylaxis between the time an initial AFB positive blood sample was collected and study entry.\n* Aminoglycosides, quinolones, clofazimine, or rifamycins IF ADMINISTERED IN ANY COMBINATION within 7 days prior to study entry OR between the time an initial AFB positive blood sample was collected and study entry."}, "identificationModule"=>{"nctId"=>"NCT00001039", "briefTitle"=>"Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"The Effect of Therapy on the Tissue Burden of Disseminated MAC Infection as Measured by Quantitative Bone Marrow Culture and Correlation With Quantitative Blood Culture in HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"DATRI 007"}, "secondaryIdInfos"=>[{"id"=>"11739", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry ID"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ethambutol hydrochloride", "type"=>"DRUG"}, {"name"=>"Clarithromycin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85724", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Univ of Arizona / Health Science Ctr", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ of Maryland at Baltimore", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"08103", "city"=>"Camden", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - New Jersey Med School / Cooper Hosp", "geoPoint"=>{"lat"=>39.92595, "lon"=>-75.11962}}, {"zip"=>"122083479", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / Division of HIV Medicine A158", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"117948153", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"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"=>"23219", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"Richmond AIDS Consortium", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}], "overallOfficials"=>[{"name"=>"Hafner R", "role"=>"STUDY_CHAIR"}, {"name"=>"Drusano G", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
