The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 90-day Cryptococcal Meningitis (CM) related mortality
研究概览
简要总结
Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared.
详细描述
HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.
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
- •Clinical diagnosis of HIV infection;
- •newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);
- •Anti-viral treatment naïve patients
- •anti-fungal treatment naïve patients
排除标准
- •hepatitis virus co-infection;
- •liver cirrhosis;
- •congestive heart failure;
- •chronic renal disorders;
- •chronic obstructive pulmonary disease (COPD);
- •Tuberculosis co-infection;
- •malignances
- •severe mental and neurological diseases
- •Women during pregnancy and lactation
- •intraveneous drug user (IDU)
- •patients with follow abnormal test results:hemoglobin < 6 g/dl, white blood cell count < 2000 / μl, neutrophil count < 1000 / μl, platelet count < 75000 / μl, blood amylase > 3 times normal level Upper limit, serum creatinine > 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase > 3 times normal upper limit, total bilirubin > 2 times normal upper limit
- •patients who are unwilling to anticipate.
研究组 & 干预措施
voriconazole treatment
induction treatment with Voriconazole 200mg bid (IV) + 5FC (100mg/kg/d) for 14 days, consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d
干预措施: Voriconazole 200mg (Drug)
amphotericin treatment (0.7-1.0mg/kg/d)
Induction treatment with amphotericin B 0.7-1.0mg/kg/d + 5FC (100mg/kg/d) for 14 days,consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d
干预措施: Amphotericin B-deoxycholate (0.7-1.0mg/kg/d) (Drug)
amphotericin B treatment (0.4-0.5mg/kg/d)
Induction treatment with amphotericin B 0.4-0.5mg/kg/d + 5FC (100mg/kg/d) for 28 days, consolidation treatment with fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d
干预措施: amphotericin B deoxycholate (0.4-0.5mg/kg/d) (Drug)
结局指标
主要结局
90-day Cryptococcal Meningitis (CM) related mortality
时间窗: 90 days
analysis of 90-day CM-related mortality of patients in three induction treatments
次要结局
- Early fungicidal rate in Cerebrospinal fluid (CSF)(2 weeks)
- Hypokalemia(0-90 days)
- anemia(0-90 days)
- creatinine elevation(0-90 days)