PACTR202211865409139招募中2 期
Preventing tuberculosis relapse and chronic lung disease: a proof-of-concept, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of atorvastatin to reduce inflammation after tuberculosis treatment completion in HIV-infected and HIV-uninfected adults measured by FDG-PET/CT
niversity of Cape Town0 个研究点目标入组 342 人开始时间: 2022年11月22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
- 342
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
- •1. Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing
- •2. Age 18 to 65 years with body weight from 50 kg to 90 kg
- •3. Clinical response to TB treatment and sputum culture negative at week 16
- •4. Completed a course of standard TB treatment
- •Laboratory parameters within 30 days before enrolment:
- •5. For HIV-infected participants: suppressed HIV viral load within 30 days prior to enrolment
- •6. AST and ALT <3x upper limit of normal (ULN)
- •7. Creatinine <2x ULN
- •8. Hemoglobin >7.0 g/dL
- •9. Platelet count >50 x109 cells/L
- •10. Creatinine kinase <2x ULN
- •11. Able and willing to return to follow-up
- •12. Willing to have samples, including DNA, stored
- •13. Willing to consistently practice a highly reliable method of pregnancy prevention
排除标准
- •1. Acute illness
- •2. Fever (temperature >38.0 degrees centigrade)
- •3. Participant receiving any type of lipid lowering agent at the time of screening, within three months prior to screening or likely to require any lipid lowering agent in the near future.
- •4. Known allergy or contraindications to the investigational drug or any other statins
- •5. Any drug with significant drug-drug interaction that increase exposure to atorvastatin and potentially the risk for the participants (E.g. protease inhibitors)
- •6. Evidence of drug-resistant TB
- •7. Extrapulmonary TB, including pleural TB and/or large pleural effusion
- •8. Pregnant or desiring/trying to become pregnant in the next 6 months
- •9. Unable to take oral medications
- •10. Diabetes as defined by HbA1c=6.5, random glucose=200mg/dL (or 11.1mmol/L), fasting plasma glucose=126mg/dL (or 7.0mmol/L), or the presence of any anti-diabetic agent as a concomitant medicine
- •11. Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)
- •12. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
- •13. Use of any investigational drug in the previous 3 months
- •14. Alcohol and substance abuse which might interfere with medication adherence during the trial
- •15. Any person for whom the physician feels this study is not appropriate
- •16. Positive SARS-CoV-2 PCR or SARS-CoV-2 Rapid Antigen Test in the past 4 weeks
- •17. Claustrophobia - only for patients opting to undergo cardiac MRI
- •18. Pacemaker, bullet injury or ferromagnetic device or surgical clip (e.g. brain aneurysm clip, aortic clip, heart valve, insulin pump, IUD, joint replacement, protheses, wire sutures, dentures) - only for patients opting to undergo cardiac MRI
- •19. Allergy to CMR contrast media - only for patients opting to undergo cardiac MR
研究者
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