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\u002F Bronx Municipal Hosp","10467",{"type":55,"coordinates":180},[141,142],{"lat":142,"lon":141},{"facility":183,"status":7,"city":137,"state":73,"zip":178,"country":52,"countryCode":53,"cosmosGeoPoint":184,"geoPoint":186,"contacts":7},"North Central Bronx Hosp \u002F Bronx Municipal Hosp",{"type":55,"coordinates":185},[141,142],{"lat":142,"lon":141},{"type":188,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100053884","a-prospective-study-of-multidrug-resistance-and-a-pilot-study-of-the-safety-of-and-clinical-and-microbiologic-response-to-levofloxacin-in-combination-with-other-antimycobacterial-drugs-for-treatment-of-multidrug-resistant-pulmonary-tuberculosis-mdrtb-in-hiv-infected-patients-100053884",false,"NCT00000796","A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.","Inclusion Criteria\n\nPatients must have:\n\n* Working diagnosis of HIV infection.\n* Working diagnosis of pulmonary TB.\n\nPer 08\u002F02\u002F94 amendment, patients with confirmed MDRTB or known susceptibilities for the current episode at baseline are not eligible for the epidemiologic study only.\n\nFOR TREATMENT PILOT:\n\n* Positive sputum AFB smear (or a positive sputum culture for TB within 6 months prior to study entry).\n* Assessment of suspect primary, suspect acquired, AND\u002FOR confirmed MDRTB.\n* Life expectancy of at least 2 weeks.\n* Age \\>= 18 years for suspect MDRTB. Age \\>= 13 years for confirmed MDRTB.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Known hypersensitivity or resistance to quinolones.\n* Other disorders or conditions for which the study drugs are contraindicated.\n\nPrior Medication:\n\nExcluded:\n\n* More than 6 weeks total therapy within 3 months prior to study entry using three or more drugs effective against the isolates. (Per 08\u002F02\u002F94 amendment, patients from protocol ACTG 222\u002FCPCRA 019 who have MDRTB are eligible for rollover to this study regardless of treatment duration on ACTG 222\u002FCPCRA 019.)","ALL","13 Years",{"count":198,"type":7},525,"INTERVENTIONAL",[201],"NA","To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9\u002F28\u002F94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain.\n\nAmong TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.",[204,205],"HIV Infections","Tuberculosis",[25,207,27,208,209,33,210,211,212,35,213,214,215,11,216,13,217,218,219],"Tuberculosis, Pulmonary","Pyridoxine","Ofloxacin","AIDS-Related Opportunistic Infections","Drug Therapy, Combination","Ethambutol","Acquired Immunodeficiency Syndrome","Amikacin","Drug Resistance, Microbial","Capreomycin Sulfate","Aminosalicylic Acids","Streptomycin","p-Aminosalicylic Acid","COMPLETED","2021-10-27",{"date":223,"type":224},"2021-11-03","ACTUAL",{"date":226,"type":224},"1998-10",{"name":5,"class":6},21]