Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Absence of clinical kala-azar at six month follow up
研究概览
简要总结
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.
详细描述
In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.
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
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
- •Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
- •Male or female.
- •Ages 12 to 65 years.
- •Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
- •WBC > 1,000/mm
- •Hemoglobin ≥ 4 g/dL
排除标准
- •Pregnancy or breast-feeding.
- •HIV positive serology.
- •ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
- •Bilirubin ≥ 2 times upper limit of normal range.
- •Prothrombin time ≥ 5 seconds above control.
- •Serum creatinine or BUN ≥ 1.5 times upper limit of normal range.
- •Any medical condition or situation that compromises compliance with study procedures.
结局指标
主要结局
Absence of clinical kala-azar at six month follow up
次要结局
未报告次要终点