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临床试验/NCT00023348
NCT00023348已完成2 期

TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Centers for Disease Control and Prevention43 个研究点 分布在 2 个国家目标入组 150 人开始时间: 1999年7月最近更新:
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试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
43
主要终点
To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary Objectives:

  1. To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.

Secondary Objectives:

  1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
  2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
  3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
  4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

详细描述

This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.

次要结局

  • 1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
  • 2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
  • 3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
  • 4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

研究者

申办方类型
Fed

研究点 (43)

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