NCT00023361已完成不适用
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Centers for Disease Control and Prevention23 个研究点 分布在 2 个国家目标入组 215 人开始时间: 1999年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 23
- 主要终点
- Rate of confirmed treatment failure and relapse
研究概览
简要总结
Primary objective:
To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of pulmonary &/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
- •Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
- •Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
- •> 18 years of age
- •Willingness to practice effective contraception if applicable
- •Signed informed consent
排除标准
- •Pregnancy or breastfeeding
- •AST > 10 times the upper limit of normal
- •Bilirubin > 3.0 times the upper limit of normal
- •Creatinine > 3.0 times the upper limit of normal
- •Intolerance to any of the study drugs except isoniazid or pyrazinamide
- •Concomitant disorder that is contraindication to the use of the study drugs
- •More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
- •Bone/joint tuberculosis or silicotuberculosis
结局指标
主要结局
Rate of confirmed treatment failure and relapse
次要结局
- Safety and tolerability
- Response of HIV RNA to TB treatment
- Paradoxical reactions
研究者
研究点 (23)
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