Phase II Study of Daily Rifapentine for Pulmonary Tuberculosis (IND 62,611; 1/2/0

每日利福喷丁治疗肺结核的 II 期研究（IND 62,611；1/2/0

• 批准号: 8141454
• 负责人: Susan E Dorman
• 金额: $ 40万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8141454
• 关键词: Phase; II; Study; Daily; Rifapentine

DESCRIPTION (provided by the applicant): There is a need for highly potent TB treatments that can cure disease in substantially fewer than the six months currently required. Rifapentine is a long-acting rifamycin that has potent anti-TB activity and is currently FDA-approved for TB treatment at a dose of 600 mg twice weekly. Evidence using a mouse model of TB treatment indicates that a multi-drug regimen containing daily rifapentine can cure TB within three to four months. However, there are critical knowledge gaps; the efficacy of daily rifapentine has not been assessed in clinical trials and the optimal dose of once daily rifapentine for clinical use is not known. Preclinical and Phase 1 studies suggest that the optimal daily dose is likely to lie between 450 and 600 mg. The overall goal of this proposal is to determine the optimal daily dose of rifapentine in the context of multidrug intensive phase treatment for pulmonary TB, in order to guide dose selection for future Phase 3 clinical trials. The proposed Phase 2 clinical trial is intended to determine the antimicrobial activity and safety of rifapentine doses of 450 mg and 600 mg administered once daily with isoniazid, pyrazinamide, and ethambutol during intensive phase (first eight weeks) treatment of smear-positive pulmonary TB in Cape Town, South Africa.

描述（申请人提供）： 需要高度有效的结核病治疗，可以治愈疾病的少于目前所需的六个月。利福丁是一种长效的利福米霉素，具有有效的抗TB活性，目前每周两次以600 mg的剂量为600毫克FDA批准用于结核病治疗。使用TB治疗的小鼠模型的证据表明，包含每日利福丁的多药方案可以在三到四个月内治愈结核病。 但是，存在关键的知识差距。在临床试验中尚未评估每日利福丁的疗效，每天一次利福丁的最佳剂量供临床使用。临床前和第1阶段的研究表明，最佳每日剂量可能位于450至600 mg之间。该提案的总体目标是确定在多药密集期治疗肺结核的情况下，利福丁的每日剂量的最佳剂量，以指导未来3期临床试验的剂量选择。拟议的2期临床试验旨在确定每天每天使用Isoniaiazid，iniazinamide和Ethambutol施用的450 mg和600 mg的小脚素剂量的抗菌活性和安全性，在强化阶段（前八周）治疗南非南非斗篷的Smear阳性肺部TB的治疗。