The Efficacy and Safety Evaluation of Standardized Treatment Included Rifampicin or Rifabutin in HIV/AIDs Patients Combined With Pulmonary Tuberculosis. A Prospective Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- The rate of sputum negative conversion
研究概览
简要总结
To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.
详细描述
Two hundreds and thirty participants will be randomly assigned to receive an anti--tuberculosis treatment include rifampicin or rifabutin for two months of intensive therapy. Isoniazid and rifampicin (or rifabutin) will be continued to use for four months of consolidation therapy. A total of followed up period will be 12 months.
The antiretroviral therapy（ART） include:
Tenofovir disoproxil fumarate 300mg/d +Lamivudine 300mg/d+ Efavirenz 600mg/d; or Zidovudine 300mg bid +Lamivudine 300mg/d +Efavirenz 600mg/d.
ART will be started after 2 weeks of anti-tuberculosis.
The follow-up visits include 2th, 4th, 6th, 8th, 12th,16th, 20th, 24th, 32th, 36th, 40th, 44th and 48th week. sputum smear, sputum culture, chest X-ray, CD4 Lymphocyte counts,HIV viral load and adverse event will be tested and recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years old;
- •No limited to gender;
- •If anti-HIV-1 positive samples are detected by an initial test based on the ELISA method, they should be confirmed by western blot;
- •The patients who are diagnosed with pulmonary TB (mycobacterium tuberculosis of sputum smear or culture was positive) but had never be treated;
- •Sign informed consent form voluntarily, and guarantee to attend follow-up visits;
- •Do not have plan to remove from the current experimental site during the trial process;
- •The patients do not receive any antiretroviral treatment before;
- •The overall situation of the patient should not affect the assessment and completion of the trial.
排除标准
- •Patients with acute infection;
- •During the screening period，patients with combined opportunistic infections and instability (National HIV/AIDS treatment guidelines) except for tuberculosis, or combined malignancy;
- •During the screening period，hemachrome < 6 g/dl, leukocyte < 2000 /µl, neutrophils < 1000 /µl, platelet count < 75000 /µl, blood amylase is greater than two times the upper limit of normal, Scr is greater than1.5 times the upper limit of normal, AST/ALT/AKP is greater than two times the upper limit of normal, TBIL is greater than two times the upper limit of normal, serum CK is greater than two times the upper limit of normal;
- •Now suffering from acute or chronic pancreatitis;
- •Now suffering from peripheral neuritis;
- •Pregnant and lactating women;
- •Patients with severe mental and neurological diseases;
- •Drug users；
- •Patients with history of heavy drinking and cannot be terminated;
- •Serious gastrointestinal ulcers；
- •Atherosclerosis affects the arteries in the heart, brain or kidneys；
- •Non-Chinese nationality；
- •Now suffering from myopathy；
- •Patients with previously treated tuberculosis.
研究组 & 干预措施
Rifampicin group
Rifampicin group: Intensive treatment（4 types of anti-TB medicines）for 2 months, then isoniazid and rifampicin for 4 months of consolidation therapy.
isoniazid: 10-15mg/kg rifampicin: 10-20mg/kg pyrazinamide: 30-40mg/kg thambutol: 0.75(W<50kg)；1.0 g/d（W≥50kg）
干预措施: Rifampicin (Drug)
Rifabutin group
Rifabutin group: Intensive treatment（4 types anti-TB medicines）for 2 months,then isoniazid and rifabutin for 4 months of consolidation therapy.
isoniazid: 10-15mg/kg rifabutin: 0.45g/d(W<50kg); 0.6g/d( W≥50kg） pyrazinamide: 30-40mg/kg thambutol: 0.75(W<50kg)；1.0 g/d（W≥50kg）
干预措施: Rifabutin (Drug)
结局指标
主要结局
The rate of sputum negative conversion
时间窗: 2~24 weeks
The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.
Case fatality rate
时间窗: 12 months
The number of deaths during follow-up caused by HIV/AIDS and TB / the number of patients with HIV/AIDs and TB enrolled in this study \* 100%.
次要结局
- Chest CT scans improvement(2~24 weeks)
- The percentage of HIV viral load less than the detection limit(6 months and 12 months)
- Treatment completion status(12 months)
- Time of sputum negative conversion(2~24 weeks)
- AE(12 months)
研究者
Hongzhou Lu
vice director
Shanghai Public Health Clinical Center