NCT03196921撤回1 期
A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Tolerability of drug over 14 days of dosing
研究概览
简要总结
This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG
排除标准
- •Presence of jaundice or known liver cirrhosis, >72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits
研究组 & 干预措施
Symptomatic Cryptococcal Meningitis
Experimental
CAMB (Encochleated Amphotericin B)
干预措施: Encochleated Amphotericin B (Drug)
Asymptomatic Cryptococcal Antigenemia
Experimental
CAMB (Encochleated Amphotericin B)
干预措施: Encochleated Amphotericin B (Drug)
结局指标
主要结局
Tolerability of drug over 14 days of dosing
时间窗: 14-days
Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses
Microbiologic clearance of Cryptococcus from the CSF
时间窗: 14-days
次要结局
- Pharmacokinetics(24-hours)
- Incidence of adverse events(14-days)
- Survival from cryptococcal infection(10-weeks)
研究者
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