RIFAPENDINE/ISONIAZID FOR 3 MONTHS VS 9 MO FOR LATENT TB (STUDY 26) (HIV)

利福平/异烟肼 3 个月与 9 个月治疗潜伏性结核病（研究 26）（HIV）

• 批准号: 7627500
• 负责人: MARC H WEINER
• 金额: $ 9.2万
• 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/7627500
• 关键词: Adolescent; Age; Antibiotic Resistance; Child; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Drug toxicity; Effectiveness; Enrollment; Funding; Grant; HIV; Household; Hypersensitivity skin testing; Institution; Label; Methadone; Mycobacterium tuberculosis; Participant; Patients; Pattern; Persons; Pharmaceutical Preparations; Phase; Randomized; Rate; Reaction; Research; Research Personnel; Resources; Risk; Self-Administered; Site; Source; Treatment Protocols; Tuberculin; Tuberculosis; United States National Institutes of Health; Upper arm; Vitamin B6; Week; Withdrawal; compare effectiveness; follow-up; isoniazid; latent infection; prevent; prospective; rifapentine

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 objective is to evaluate the effectiveness of a three-month, 12-dose regimen of weekly rifapentine plus isoniazid (3RPT/INH) compared to the effectiveness of a nine-month, 270 dose regimen of daily isoniazid (9INH) in preventing TB in high-risk tuberculin skin-test reactors. Secondary objectives are: to compare the rates of drug discontinuation due to adverse drug reactions or for any reason associated with 3RPT/INH and 9INH; to compare the rates of any grade 3, 4, or 5 drug toxicity associated with 3RPT/INH and 9INH; to compare treatment completion rates of 3RPT/INH and 9INH; to compare the efficacy of 3RPT/INH and 9INH among persons who complete study-phase therapy; to compare the effectiveness and tolerability of 3RPT/INH and 9INH in HIV-infected persons; to compare the rates of methadone withdrawal associated with 3RPT/INH and 9INH among persons concomitantly receiving methadone; and to describe patterns of antibiotic resistance among Mycobacterium tuberculosis isolates in patients who develop tuberculosis despite treatment of latent infection. RESEARCH PLAN: This trial will be conducted among high-risk tuberculin skin-test reactors, including HIV-infected persons, who require treatment of latent infection to prevent tuberculosis. We do not plan to enroll children or adolescents under the age of 18 at this site. The weekly rifapentine (900 mg for persons weighing more than 50 kg or 750 mg for persons weighing 50 kg or less) and isoniazid (15 mg/kg) regimen will be given under direct observation and the daily isoniazid (5 mg/kg) regimen will be primarily self-administered. Pyridoxine (vitamin B6) 50 mg will be given with each dose of isoniazid in both study arms. Close contacts will be randomized by household; others will be randomized individually. All participants will be followed for 33 months after initiation of study-phase therapy. Subjects will be seen every four weeks during study-phase therapy. Post-therapy follow-up will occur every three months until 21 months after enrollment, and every six months thereafter. METHODS: This is an open-label, multi-center, prospective, randomized study to evaluate the effectiveness of 3RPT/INH compared to the effectiveness of 9INH conducted among high-risk tuberculin skin-test reactors who require treatment of latent infection to prevent tuberculosis.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 目的：主要目的是评估每周三个月，12剂的12剂治疗方案（3RPT/INH）的有效性，与每天270个，270剂剂量的异oni剂量（9INH）的有效性相比，相比之下。 次要目标是：比较由于不良药物反应或出于与3RPT/INH和9INH相关的任何原因而导致的药物停用率；比较与3rpt/inh和9inh相关的任何3、4或5级药物毒性的速率；比较3RPT/INH和9inh的治疗完成率；比较完成研究期治疗的人的3RPT/INH和9inh的功效；比较3RPT/INH和9inh在感染HIV的人中的有效性和耐受性；比较同时接受美沙酮的人中与3RPT/INH和9inh相关的美沙酮戒断率；并描述结核分离株分离株中抗生素抗性的模式，尽管患有潜在感染治疗结核病。 研究计划：该试验将在高危结核蛋白皮肤测试反应堆中进行，包括受HIV感染的人，他们需要治疗潜在感染以防止结核病。 我们不打算在此站点注册18岁以下的儿童或青少年。 在直接观察下，每周的人（对重50公斤或更少的人的体重超过50 kg或750 mg）的人（对50公斤或更少的人的体重超过50千克或750毫克）的人（15 mg/kg）方案将主要观察和以isoniazid（15 mg/kg）的疗法，并且将主要是自我自我自动化的。 在两个研究臂中，每剂量的异念珠菌都将给予吡ido醇（维生素B6）50 mg。 亲密接触将由家庭随机分配；其他人将被单独进行随机。 开始研究期治疗后，所有参与者将在33个月内进行。 在研究期治疗期间，每四个星期将看到受试者。 治疗后的随访每三个月进行，直到入学后21个月以及此后每六个月进行一次。 方法：这是一项开放标签，多中心的，前瞻性的随机研究，可评估3RPT/INH的有效性，与在需要潜在感染治疗的高风险结核蛋白型肤色反应器中进行的9Iinh的有效性相比。