[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053730":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":22,"centralContacts":7,"locations":28,"responsibleParty":170,"collaborators":7,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":7,"eligibilityCriteria":177,"healthyVolunteers":174,"sex":178,"minAge":179,"maxAge":7,"enrollmentInfo":180,"targetDuration":7,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":197,"whyStopped":7,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":7,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,[9,12,14,16,18,20],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Ciprofloxacin hydrochloride",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"Ethambutol hydrochloride",{"type":10,"name":15,"description":7,"armGroupLabels":7,"otherNames":7},"Amikacin sulfate",{"type":10,"name":17,"description":7,"armGroupLabels":7,"otherNames":7},"Azithromycin",{"type":10,"name":19,"description":7,"armGroupLabels":7,"otherNames":7},"Rifampin",{"type":10,"name":21,"description":7,"armGroupLabels":7,"otherNames":7},"Clofazimine",[23,26],{"name":24,"affiliation":7,"role":25},"DM Parenti","STUDY_CHAIR",{"name":27,"affiliation":7,"role":25},"J Ellner",[29,42,52,61,66,76,85,90,95,104,114,123,131,141,150,160],{"facility":30,"status":7,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":7},"Harbor-UCLA Med. Ctr. CRS","Torrance","California","90502","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-118.34063,33.83585,{"lat":40,"lon":39},{"facility":43,"status":7,"city":44,"state":45,"zip":46,"country":34,"countryCode":35,"cosmosGeoPoint":47,"geoPoint":51,"contacts":7},"Indiana Univ. School of Medicine, Infectious Disease Research Clinic","Indianapolis","Indiana","46202",{"type":37,"coordinates":48},[49,50],-86.15804,39.76838,{"lat":50,"lon":49},{"facility":53,"status":7,"city":54,"state":55,"zip":7,"country":34,"countryCode":35,"cosmosGeoPoint":56,"geoPoint":60,"contacts":7},"St. Louis ConnectCare, Infectious Diseases Clinic","St Louis","Missouri",{"type":37,"coordinates":57},[58,59],-90.19789,38.62727,{"lat":59,"lon":58},{"facility":62,"status":7,"city":54,"state":55,"zip":7,"country":34,"countryCode":35,"cosmosGeoPoint":63,"geoPoint":65,"contacts":7},"Washington U CRS",{"type":37,"coordinates":64},[58,59],{"lat":59,"lon":58},{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":34,"countryCode":35,"cosmosGeoPoint":71,"geoPoint":75,"contacts":7},"NJ Med. School CRS","Newark","New Jersey","07103",{"type":37,"coordinates":72},[73,74],-74.17237,40.73566,{"lat":74,"lon":73},{"facility":77,"status":7,"city":78,"state":78,"zip":79,"country":34,"countryCode":35,"cosmosGeoPoint":80,"geoPoint":84,"contacts":7},"NY Univ. HIV\u002FAIDS CRS","New York","10016",{"type":37,"coordinates":81},[82,83],-74.00597,40.71427,{"lat":83,"lon":82},{"facility":86,"status":7,"city":78,"state":78,"zip":7,"country":34,"countryCode":35,"cosmosGeoPoint":87,"geoPoint":89,"contacts":7},"Beth Israel Med. Ctr. (Mt. Sinai)",{"type":37,"coordinates":88},[82,83],{"lat":83,"lon":82},{"facility":91,"status":7,"city":78,"state":78,"zip":7,"country":34,"countryCode":35,"cosmosGeoPoint":92,"geoPoint":94,"contacts":7},"NYU Med. Ctr., Dept. of Medicine",{"type":37,"coordinates":93},[82,83],{"lat":83,"lon":82},{"facility":96,"status":7,"city":97,"state":78,"zip":98,"country":34,"countryCode":35,"cosmosGeoPoint":99,"geoPoint":103,"contacts":7},"Univ. of Rochester ACTG CRS","Rochester","14642",{"type":37,"coordinates":100},[101,102],-77.61556,43.15478,{"lat":102,"lon":101},{"facility":105,"status":7,"city":106,"state":107,"zip":108,"country":34,"countryCode":35,"cosmosGeoPoint":109,"geoPoint":113,"contacts":7},"Unc Aids Crs","Chapel Hill","North Carolina","27599",{"type":37,"coordinates":110},[111,112],-79.05584,35.9132,{"lat":112,"lon":111},{"facility":115,"status":7,"city":116,"state":107,"zip":117,"country":34,"countryCode":35,"cosmosGeoPoint":118,"geoPoint":122,"contacts":7},"Duke Univ. Med. Ctr. Adult CRS","Durham","27710",{"type":37,"coordinates":119},[120,121],-78.89862,35.99403,{"lat":121,"lon":120},{"facility":124,"status":7,"city":125,"state":107,"zip":7,"country":34,"countryCode":35,"cosmosGeoPoint":126,"geoPoint":130,"contacts":7},"Regional Center for Infectious Disease, Wendover Medical Center CRS","Greensboro",{"type":37,"coordinates":127},[128,129],-79.79198,36.07264,{"lat":129,"lon":128},{"facility":132,"status":7,"city":133,"state":134,"zip":135,"country":34,"countryCode":35,"cosmosGeoPoint":136,"geoPoint":140,"contacts":7},"Univ. of Cincinnati CRS","Cincinnati","Ohio","45267",{"type":37,"coordinates":137},[138,139],-84.51439,39.12711,{"lat":139,"lon":138},{"facility":142,"status":7,"city":143,"state":134,"zip":144,"country":34,"countryCode":35,"cosmosGeoPoint":145,"geoPoint":149,"contacts":7},"Case CRS","Cleveland","44106",{"type":37,"coordinates":146},[147,148],-81.69541,41.4995,{"lat":148,"lon":147},{"facility":151,"status":7,"city":152,"state":153,"zip":154,"country":34,"countryCode":35,"cosmosGeoPoint":155,"geoPoint":159,"contacts":7},"Pitt CRS","Pittsburgh","Pennsylvania","15213",{"type":37,"coordinates":156},[157,158],-79.99589,40.44062,{"lat":158,"lon":157},{"facility":161,"status":7,"city":162,"state":163,"zip":164,"country":34,"countryCode":35,"cosmosGeoPoint":165,"geoPoint":169,"contacts":7},"University of Washington AIDS CRS","Seattle","Washington","98122",{"type":37,"coordinates":166},[167,168],-122.33207,47.60621,{"lat":168,"lon":167},{"type":171,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100053730","phase-2-a-phase-iiiii-trial-of-rifampin-ciprofloxacin-clofazimine-ethambutol-and-amikacin-in-the-treatment-of-disseminated-mycobacterium-avium-infection-in-hiv-infected-individuals-100053730",false,"NCT00000641","A Phase II\u002FIII Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.","Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT) and didanosine (ddI). Dideoxycytidine (ddC), EPO, and other experimental therapies granted Treatment IND or Expanded Access status, with the exception of rifabutin.\n* Concurrent therapies (acute and maintenance) for opportunistic infections not specifically prohibited.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Interferon-alfa.\n\nPatients must have the following:\n\n* HIV infections or diagnosis of AIDS as per CDC classification.\n* Mycobacterium avium isolated from blood.\n* Capability of signing an informed consent, or consent of guardian if \\\u003C 18 years of age.\n* Ability and willingness to participate in all components of the study and receive all study therapies.\n\nPrior Medication:\n\nAllowed:\n\n* Interferon-alfa.\n* Single drug prophylaxis for Mycobacterium avium or M. tuberculosis within the previous 4 weeks.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nTreatment Phase:\n\n* Known or suspected allergy to any of the study medications. Severe hearing loss.\n\nMaintenance Phase:\n\n* Severe hearing loss. Hypersensitivity to macrolides. Intolerance to ethambutol and clofazimine.\n\nConcurrent Medication:\n\nExcluded:\n\n* Acute therapy for other opportunistic infections at time of study entry.\n* Nephrotoxic agents such as amphotericin B, intravenous vancomycin, or foscarnet during the first 4 weeks of study therapy without specific exemption from one of the protocol chairs. Antacids within 2 hours of ingestion of study drugs.\n* Immunomodulators (except interferon-alfa) and other antimycobacterial drugs (including quinolones and aminoglycosides).\n* All experimental therapies (except ddI, ddC, and other experimental agents granted \"Treatment IND\" or \"expanded access\" status) will be prohibited (specific exemptions must be obtained from one of the protocol chairs).\n\nPatients with the following are excluded:\n\n* Known or suspected allergy to any of the study medications. Cannot take drugs orally.\n* Severe hearing loss, at the discretion of the investigator.\n\nPrior Medication:\n\nExcluded:\n\n* Antimycobacterial drugs (including azithromycin, clarithromycin, rifamycins, quinolones, and aminoglycosides) or immunomodulators (except interferon-alfa) within 4 weeks prior to entry, except single-drug prophylaxis specifically allowed.\n\nHistory of unreliable drug intake.\n\n* Inability to cooperate in the testing procedures.","ALL","13 Years",{"count":181,"type":7},90,"INTERVENTIONAL",[184],"PHASE2","To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. \\[Per 03\u002F06\u002F92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.\\] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).",[187,188],"Mycobacterium Avium-intracellulare Infection","HIV Infections",[19,190,191,192,193,21,194,195,17,196],"Mycobacterium avium-intracellulare Infection","Drug Evaluation","Drug Therapy, Combination","Ethambutol","Acquired Immunodeficiency Syndrome","Amikacin","Ciprofloxacin","COMPLETED","2021-10-26",{"date":200,"type":201},"2021-11-03","ACTUAL",{"date":203,"type":201},"1994-12",{"name":5,"class":6},16]