NCT00023426已完成2 期
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
Centers for Disease Control and Prevention23 个研究点 分布在 2 个国家目标入组 150 人开始时间: 1999年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 23
- 主要终点
- Proportion of patients who fail to complete therapy in each of the dosing groups
研究概览
简要总结
Randomized, double-blind study of the tolerability of three different doses of rifapentine
详细描述
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusions:
- •Drug susceptible culture-positive tuberculosis
- •Adequate induction therapy
- •Normal screening labs
- •Karnofsky >=60
- •Informed consent
- •Birth control if of child bearing potential
- •Exclusions:
- •Skeletal or CNS TB
- •Pregnant or breastfeeding
- •Intolerance to INH or rifamycins
- •Over 70 days TB treatment just prior to enrollment
排除标准
- 未提供
结局指标
主要结局
Proportion of patients who fail to complete therapy in each of the dosing groups
次要结局
- 1. Rate of serious adverse events in each of the dosing groups
- 2. Rate of total adverse events in each of the groups
- 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups
研究者
研究点 (23)
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