CLINICAL TRIAL: RIFAPENTINE/ISONIAZID FOR 3 MONTHS VS 9 MO FOR LATENT TB (STUDY

临床试验：利福喷丁/异烟肼治疗潜伏性结核病 3 个月与 9 个月（研究

• 批准号: 7718707
• 负责人: MARC H WEINER
• 金额: $ 1.35万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718707
• 关键词: Adolescent; Age; Antibiotic Resistance; Child; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Drug toxicity; Effectiveness; Enrollment; Funding; Grant; 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目的：主要目的是评价3个月、每周12次剂量的利福喷丁加异烟肼（3RPT/INH）方案与9个月、每日270次剂量的异烟肼（9 INH）方案在预防高危结核菌素皮试反应者结核病方面的有效性。 次要目的是：比较由于药物不良反应或与3RPT/INH和9 INH相关的任何原因而停药的比率;比较与3RPT/INH和9 INH相关的任何3、4或5级药物毒性的比率;比较3RPT/INH和9 INH的治疗完成率;比较3RPT/INH和9 INH在完成研究阶段治疗的人中的功效;比较3RPT/INH和9 INH在HIV感染者中的有效性和耐受性;比较伴随接受美沙酮的人中与3RPT/INH和9 INH相关的美沙酮戒断率;描述尽管治疗了潜伏感染但仍发展为结核病的患者中结核分枝杆菌分离株的抗生素耐药性模式。 研究报告：这项试验将在高风险结核菌素皮试反应者中进行，包括艾滋病毒感染者，他们需要治疗潜伏感染以预防结核病。 我们不计划在本研究中心招募18岁以下的儿童或青少年。 将在直接观察下给予每周一次利福喷丁（体重超过50 kg的患者为900 mg，体重小于或等于50 kg的患者为750 mg）和异烟肼（15 mg/kg）方案，每日一次异烟肼（5 mg/kg）方案将主要自我给药。 在两个研究组中，吡哆醇（维生素B6）50 mg将与每次异烟肼给药同时给药。 密切接触者将按家庭随机分配;其他人将单独随机分配。 所有受试者将在研究阶段治疗开始后随访33个月。 在研究阶段治疗期间，将每四周对受试者进行一次访视。 治疗后随访将每3个月进行一次，直至入组后21个月，此后每6个月进行一次。 方法：这是一项开放标签、多中心、前瞻性、随机研究，旨在评价3RPT/INH与9 INH在需要治疗潜伏感染以预防结核病的高危结核菌素皮试反应者中的有效性。