EUCTR2004-005142-12-GB进行中（未招募）1 期
An open-label study to evaluate the extended early bactericidal activity, safety, tolerability and pharmacokinetics of multiple doses (m.d.) of TMC207 oral solution (os) and isoniazid (JH), m.d. of TMC207 os and pyrazinamide (JZ), m.d. of TMC207 os and rifampin (JR) or m. oral d. of TMC207 os and isoniazid and pyrazinamide (JHZ), compared to the 3 principle drugs of standard anti-tuberculosis treatment (HRZ) in treatment-naïve subjects with sputum-smear positive pulmonary tuberculosis. - N/A
Tibotec Pharmaceuticals Limited0 个研究点目标入组 60 人开始时间: 2005年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female. Females may participate if they are of non-childbearing potential or using effective non-hormonal birth control methods and willing to continue practicing these birth control methods for at least 14 days after the end of the study period.
- •2. Aged between 18 and 65 years, extremes included
- •3. Treatment-naïve subjects (or subjects who have not received treatment in the last 3 years) with sputum smear-positive pulmonary tuberculosis willing to start anti-TB therapy
- •4. Adequate sputum specimens (at least 15 mL/day), as estimated from a spot specimen collected prior to admission
- •5. Positive for acid-fast bacilli on direct spear examination of sputum specimen (i.e., < 1 acid-fast bacilli per 10 high power (100x) fields)
- •6. The participant must consent to human immuno-deficiency virus (HIV) testing
- •7. Weight as defined by a Quetelet Index (Body Mass Index, BMI) of 15.0 to 28.0 kg/m2, extremes included
- •8. Informed Consent Form signed voluntarily before first trial-related activity
- •9. The participant must agree to hospital admission
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to the study medications (including any rifamycin antibiothics)
- •2. Current or past history of alcohol and/or drug use that, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
- •3. History or presence of hepatic or gastrointestinal disease that might, in the judgment of the investigator, interfere with the absorption, distribution, metabolism or elimination of TMC207, rifampin, isoniazid, or pyrazinamide
- •4. A concomitant infection that requires and additional systemic antimicrobial agent
- •5. Subjects who have received any previous anti-mycobacterial drugs for the treatment of atypical mycobacterial infection or leprosy and subjects who have received more that 2 weeks of antibiotic treatment with a fluoroquinone drug (such as ciprofloxacin, ofloxacin, moxifloxacin)
- •6. Subjects who have received antiretroviral therapy and/or oral or intravous antifungal medication within the last 90 days and/or subjects, for whom in the opinion of the ivnestigator, early antiretroviral therapy is indicated
- •7. Presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult
- •8. Impaired hepatic function, as shown by the following:
- •- Aspartate aminotransferase (AST)> 2.5 times the upper limit of normal (ULN)
- •- Alanine aminotransferase (ALT)> 2.5 times ULN
- •- Alkaline phosphatase (ALP)>2 times ULN
- •- Total bilirubin>2.5 times ULN
- •9. Subjects how have received any other investigational medication within 30 days prior to study entry
- •10. Participation in other drug studies within 3 months (except for Brazil: within 12 months) prior to study initiation
- •11. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- •12. Unlikely to comply with the protoocl, e.g., uncooperative attitude, inability to remain hospitalized and unlikelihood of completing the study
- •13. Women how are pregnant and/or breast feeding
- •14. Previous participation in an investigational drug trial within TMC207.
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