PER-010-08已完成未知
A Phase II, Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Tibotec BVBA,0 个研究点目标入组 33 人开始时间: 2008年6月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Subjects of both sexes. Women may participate if they are not able to procreate, if they are using effective non-hormonal contraceptive methods and are willing to continue using contraceptive methods as specified in lesson 5.2.4 during treatment for MDR-TB or if they are not heterosexually active or willing to not have sex during treatment for MDR-TB.
- •18 to 65 years of age, inclusive.
- •Subjects with a new diagnosis of MDR-TB lung infection with positive sputum as defined below, with confirmed resistance to at least RMP and INH from previous screening tests in an institution for the treatment of TB, who are willing to begin treatment for TB according to national TB standards
- •Subjects positive for AFB in the direct smear examination of expectorated sputum sample (> 1 positive smear)
- •Subjects with a sputum production that can probably produce 10 ml per night
- •Subjects must consent to HIV testing unless an HIV test has been performed within a month prior to the start of the study and documentation (ELISA and / or Western Blot) can be provided.
- •Subjects should be willing to discontinue all TB drugs to allow a 7-day wash before baseline evaluations and to begin treatment with TMC207 or placebo.
- •Subjects with normal weight, defined by a Quetiet index [body mass index (BMI)] of 15.0 to 28.0 kg / m2 inclusive.
- •Subjects who have voluntarily signed the ICF before the first activity related to the study.
- •Subjects who are willing to be hospitalized according to standard care.
排除标准
- •Subjects previously treated for MDR-TB
- •Presenting suspected hypersensitivity or confirmed hypersensitivity or a serious adverse reaction to the study medication
- •Presence or history of alcohol and / or drug use that, according to the investigator´s criteria, would compromise the subject´s safety or compliance with the protocol procedures of the study.
- •Presence of a clinically significant active medical condition that, in the investigator´s judgment, does not allow the subject to participate adequately in the study
- •Presence of significant cardiac arrhythmia that requires medication
- •In the case of subjects with HIV infection, have a CD4 + count <300 cells / uL or have received antiretroviral treatment and / or oral or intravenous antifungal medication in the previous 90 days. In addition, subjects who, in the investigator´s judgment, may need to initiate antiretroviral treatment during the 24-week treatment period of stage 2, are not candidates to participate.
- •Subjects with complicated or severe extrapulmonary manifestations of TB or neurological manifestations of TB.
- •Presence of any serious concomitant disease or rapidly deteriorating health condition, including immunological deficiency, which would hinder the implementation of the protocol or the interpretation of the study results or gastrointestinal disease that could, in the investigator´s opinion, interfere with the absorption of the TMC207.
- •Subjects who, after evaluating their lung disease, required a surgical procedure to manage their TB within the 8-week treatment period of stage 1 or the 24-week treatment period of stage 2.
- •Evidence of chorioretinitis, optic neuritis or uveitis in the selection
- •Having previously participated in a study with a research drug with TMC207
- •Have participated in other clinical studies with agents in research in the 8 weeks prior to the start of the study.
- •Have completed a drug susceptibility test before screening and are not susceptible to at least 3 of the 5 classes of TB drugs used to treat MDR-TB.
- •Present any mental condition that makes the subject unable to understand the nature, scope and possible consequences of the study.
- •Unlikely to comply with the protocol, for example, not cooperating or completing the study.
- •Women who are pregnant and / or breast-feeding.
研究者
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