Pharmacokinetic and Pharmacodynamic Studies of Efficacy, Tolerability and Safety of Higher Dosage Rifapentine for Treatment of Tuberculosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- The primary objective of this study is to characterize rifapentine pharmacokinetic parameters (AUC0-24 and peak concentration) in patients with TB.
研究概览
简要总结
The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.
详细描述
This is a one-period, non-blinded, multi-center pharmacokinetic substudy of rifapentine and rifampin in patients with tuberculosis enrolled in Tuberculosis Trials Consortium (TBTC) Study 29. This PK substudy will use a convenience sample, i.e. be restricted to TBTC sites having logistical capacity for intensive pharmacokinetic sampling. These sites will have non-random selection of patients. In addition to the intensive sampling of 60 patients in this PK study, all patients receiving rifapentine in Study 29 will be eligible for sparse PK sampling as part of the parent treatment protocol.
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
- 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
- •Any patient enrolled in TBTC Study
- •Provision of informed consent for the study.
- •Willingness to be sampled in an out-patient clinic or be admitted to a General Clinical Research Center (GCRC) or hospital on one occasion
排除标准
- •Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).
研究组 & 干预措施
1
Rifapentine
干预措施: Rifapentine (Drug)
2
Rifampin
干预措施: Rifampin (Drug)
结局指标
主要结局
The primary objective of this study is to characterize rifapentine pharmacokinetic parameters (AUC0-24 and peak concentration) in patients with TB.
时间窗: on or after the 10th day from the start of Study 29 therapy
次要结局
- • To assess the pharmacodynamic effects of higher dose, daily rifapentine AUC0-24 on tolerability and safety during two months of treatment of tuberculosis.(on or after the 10th day of study therapy)
- • To assess the pharmacodynamic effect of rifapentine pharmacokinetic parameters (AUC0-24) on biomarkers of treatment activity in patients with tuberculosis.(on or after the 10th day of study therapy)
- • To assess in multivariate analyses the pharmacodynamic effect on biomarkers of treatment activity of the independent variables of rifapentine AUC0-24, HIV infection, isoniazid exposure (AUC0-12) and study site (African vs. non-African).(on or after the 10th day of study therapy)
- To determine if free (non-protein bound) rifapentine and free rifampin exposures are directly associated with anti-mycobacterial activity.(on or after the 10th day of study therapy)
- • To determine the effects of polymorphisms of transporter genes on rifampin and rifapentine pharmacokinetic parameters.(on or after the 10th day of therapy)