AN EVAL OF ACTIVITY AND TOLERABILITY OF MOXIFLOXACIN IN TX FOR TB-STUDY 27 (HIV)

德克萨斯州莫西沙星对 TB-Study 27 (HIV) 的活性和耐受性评估

• 批准号: 7627502
• 负责人: MARC H WEINER
• 金额: $ 0.8万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7627502
• 关键词: Adolescent; Adverse event; Age; Brazil; Breast Feeding; Caliber; Chest; Child; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Double-Blind Method; Enrollment; Ethambutol; Female; Funding; Gases; Geographic Locations; Grant; Institution; Medicine; Moxifloxacin; North America; Numbers; Patient currently pregnant; Patients; Persons; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Pulmonary Tuberculosis; Pyrazinamide; Randomized; Rate; Research; Research Personnel; Resources; Rifampin; Safety; Source; Sputum; Standards of Weights and Measures; Structure of parenchyma of lung; Thick; Time; Toxic effect; Treatment Failure; Treatment Protocols; Uganda; Uncertainty; United States National Institutes of Health; Upper arm; Visit; Vitamin B6; Week; Woman; day; isoniazid; male; prospective

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: The primary objectives are to compare the culture-conversion rate at the end of the four-drug (intensive) phase of therapy of the moxifloxacin regimens vs. that of the ethambutol regimens and to compare the safety and tolerability of the moxifloxacin regimens to that of the ethambutol regimens. Secondary objectives are: to compare the culture-conversion rate at the end of the four-drug phase of therapy of the daily regimens (5 days per week) vs. the intermittent regimens (thrice-weekly); to compare the safety and tolerability of the daily regimens to that of the intermittent regimens; to compare adverse events among HIV-infected patients vs. HIV-uninfected patients; to compare the rates of treatment failure of the moxifloxacin regimens to the ethambutol regimens; and to determine whether there is delayed toxicity attributable to moxifloxacin (toxicity that becomes evident after the two months of moxifloxacin therapy). RESEARCH PLAN: This trial will be conducted among male and female patients, including HIV-infected persons, who require treatment for pulmonary tuberculosis. We do not plan to enroll pregnant or breast-feeding women, children, or adolescents under the age of 18 because of uncertainties about the safety to moxifloxacin in those groups of patients. All study therapy will be administered by direct observed therapy (DOT). The study treatment groups are: - Daily control regimen: standard TB medicines (INH, rifampin, PZA, ethambutol) plus moxifloxacin placebo administered by DOT 5 to 7 days per week for 8 weeks. - Daily moxifloxacin regimen: moxifloxacin 400 mg plus standard TB medicines (INH, rifampin, PZA) and ethambutol placebo administered by DOT 5 to 7 days per week for 8 weeks. - Intermittent control regimen: standard TB medicines (INH, rifampin, PZA, ethambutol) plus moxifloxacin placebo administered by DOT 5 to 7 days a week for 2 weeks, then 3 times a week for 6 more weeks. - Intermittent moxifloxacin regimen: moxifloxacin plus standard TB medicines (INH, rifampin, PZA) and ethambutol placebo administered by DOT 5 to 7 days a week for 2 weeks, then 3 times a week for 6 more weeks. Pyrodoxine (vitamin B6) 50 mg will be given with each dose in all study arms. Eligible patients will be randomized in a 1:1:1:1 ratio to the four factorial arms. Randomization will be stratified by geographic site of enrollment (North America, Brazil, Uganda) and by the presence of cavitation, defined as a gas-containing lucent space at least 1 cm in diameter within the lung parenchyma surrounded by an infiltrate or fibrotic wall greater than 1 mm thick seen on a standard chest radiograph. Subjects will be seen every 2 weeks during the intensive therapy phase. End of intensive therapy phase is defined by number of doses: 40 doses for patients on daily regimen and 28 doses (10 daily doses, 18 thrice-weekly doses) for patients on intermittent regimen. Patients will be followed in the study until completion of the continuation phase of therapy. Visits will occur every month at 3 months, 4 months, 5 months, and 6 months. However, patients who have cavitation and a positive sputum culture at the end of the intensive phase will require extended therapy for a total of 38 weeks (9 months). Study visits for these patients will continue to occur at 7 months, 8 months, and 9 months. Patients will not be followed after the completion of therapy. METHODS: This is a double-blind, placebo-controlled, multi-center, prospective, randomized study to evaluate the effect of using moxifloxacin (Moxi) in place of ethambutol (E), in combination with isoniazid (H), rifampin(R), and pyrazinamide (Z) on 2-months culture conversion among patients with sputum smear-positive pulmonary tuberculosis.

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