ISRCTN21322548已完成不适用
A randomised controlled trial of prednisone versus placebo in the management of human immunodeficiency virus (HIV)-infected patients presenting with mild to moderate Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome after commencing Highly Active Antiretroviral Therapy
niversity of Cape Town - Research Ethics Committee, Faculty of Health Sciences (South Africa)0 个研究点目标入组 100 人开始时间: 2005年8月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 性别
- All
入选标准
- •A. Age 18 years and over
- •B. Informed consent (written)
- •C. Prior to the introduction of HAART the following criteria must be met for the diagnosis of TB-IRIS to be considered:
- •1. The patient has HIV infection
- •2. The patient should be antiretroviral-naïve (excluding receipt of antiretroviral treatment within mother to child transmission programmes ? Nevirapine single-dose with or without Zidovudine in the third trimester)
- •3. The patient has microbiologic, histologic or very strong clinical evidence of tuberculosis
- •4. There has been a documented improvement in symptoms, Karnofsky score and/or weight, resolution of fever and clinical and radiological stabilization during the intensive phase of multidrug TB therapy
- •5. That adherence with anti-TB treatment is >80%
- •6. That the infecting strain of M. tuberculosis is sensitive to rifampicin, if this result is available
- •D. Consider TB-IRIS if, within 3 months of the introduction of multi-drug HAART
- •1. Adherence with HAART is documented and the patient was on anti-tuberculous therapy when HAART commenced
- •2. There are new or recurrent constitutional symptoms PLUS one or more of:
- •i. New or expanding lymph nodes (>20 mm or >50% in volume)
- •ii. New or expanding tuberculous cold abscesses (e.g. paraspinal)
- •iii. New or expanding pulmonary infiltrates (radiographically confirmed)
- •iv. New or enlarging serous effusions (pericardial, pleural or ascitic)
- •Patients presenting with other manifestations of TB-IRIS (e.g. central nervous system [CNS] tuberculoma) will not be included in this study.
排除标准
- •1. Previous systemic steroid therapy as part of the management of tuberculosis
- •2. Pregnancy
- •3. Uncontrolled Diabetes Mellitus
- •4. Adrenal failure
- •5. Severe TB-IRIS (these cases will receive open label corticosteroids) manifested by:
- •a. Respiratory failure (pO2 <8 kPa)
- •b. Altered level of consciousness or new focal neurological signs
- •c. Compression of vital structures (e.g. bronchostenosis)
- •6. Kaposi?s sarcoma
研究者
相似试验
已完成
不适用
A randomised, placebo controlled trial of prednisone in early Henoch Schonlein PurpuraISRCTN85109383Children's Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)40
已完成
不适用
A randomised controlled trial of prednisolone for women with recurrent miscarriage and high levels of uterine natural killer cells in the endometriumSpontaneous abortionISRCTN28090716iverpool Women's NHS Foundation Trust (UK)136
进行中（未招募）
1 期
A randomised controlled trial of prednisolone for women with recurrent miscarriage and high levels of uNK cells in the endometrium - recurrent miscarriage and prednisoloneIdopathic recurrent miscarriageEUCTR2005-003307-36-GBniversity of Liverpool/Liverpool Women's Hospital694
进行中（未招募）
不适用
Randomized controlled trial of prednisolone in the treatment of osteaoarthritis of the hand - BELIOAOsteoarthritis of the handsEUCTR2005-005442-39-ATDivision of Rheumatology250
已完成
不适用
The effect of Prednisolone in reducing of recurrent abortioIdiopathic Recurrent Abortion.MiscarriageIRCT2013110915342N1Avicenna Research Institute100