PACTR201902921101705招募中2 期
Phase IIA Trial of the Safety and Tolerability of Increased Dose Rifampicin and Adjunctive Linezolic, with or without, for HIV-Associated Tuberculous Meningitis
Wellcome Trust University of Cape Town0 个研究点目标入组 100 人开始时间: 2018年11月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •HIV-1 seropositivity by rapid test, confirmed by enzyme-linked immunosorbent assay (regardless of ART status);
- •Age 18 years or older;
- •Tuberculous Meningitis defined as ‘possible’, ‘probable’ or ‘definite’ as per the published case definition[68]
排除标准
- •Rifampicin-resistant M. tb detected in any microbiological specimen;
- •History of allergy or hypersensitivity to H, E, R and Z, LZD or ASA;
- •Received more than 5 days of antitubercular therapy in the 30 days prior to screening;
- •Received a dose of ASA or any other NSAID within 2 weeks of screening;
- •CSF unobtainable by lumbar puncture or another procedure;
- •Evidence of bacterial or cryptococcal meningitis;
- •Severe concurrent uncontrolled opportunistic infection including but not limited to active cytomegalovirus-associated disease, Kaposi sarcoma, Pneumocystis jirovecii pneumonia, HIV related or unrelated malignancy or gastrointestinal bleeding;
- •Any other form of immunosuppressive therapy including antineoplastic and biologic agents apart from corticosteroids;
- •Is pregnant in the third trimester;
- •Peripheral neuropathy scoring Grade 3 or above on Brief Peripheral Neuropathy Score;
- •Any disease or condition in which the use of the standard TB drugs or any of their components is contraindicated, including but not limited to allergy to any TB drug or their components;
- •The presence of one or more of the following:
- •- Estimated glomerular filtration rate (eGFR) < 20ml/min/1.73m2 (using the Cockcroft-Gault equation)
- •- International normalised ration (INR) > 1.4 and/or clinical evidence of liver failure or decompensated cirrhosis
- •- Hemoglobin < 8.0 g/dL
- •- Platelets < 50 x109 /L
- •- Neutrophils < 0.5 x 109 cells/L;
- •The patient has any disease or condition in which any of the medicinal products listed in the section pertaining to prohibited medication (section xx) is used and cannot be safely stopped;
- •The patient has a known or suspected, current or history of drug abuse, within the past 2 years, that is, in the opinion of the investigators, sufficient to compromise the safety or cooperation of the patient
研究者
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