Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.
研究概览
简要总结
This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda.
Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy.
How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection
- •Age > or equal to15 years
- •Ability and willingness to give informed consent.
- •Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater
排除标准
- •Cannot or unlikely to attend regular clinic visits
- •History of cryptococcal infection
- •Symptomatic meningitis (confirmed by CSF CRAG+)
- •>14 days of fluconazole therapy
- •Pregnancy (confirmed by urinary or serum pregnancy test)
- •Current breastfeeding
- •Known allergy to amphotericin
研究组 & 干预措施
fluconazole (standard of care)
Standard of care pre-emptive treatment fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months
干预措施: Fluconazole (Drug)
Single dose liposomal Amphotericin and fluconazole
Experimental:
Single dose Ambisome 10mg/kg and Fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months. (standard of care therapy)
干预措施: Single dose liposomal Amphotericin and Fluconazole (Drug)
结局指标
主要结局
Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.
时间窗: 24 weeks
Comparison will be made between those randomized to single dose liposomal amphotericin + standard of care (fluconazole) vs. standard of care (fluconazole) alone
次要结局
- Number of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scale(within two weeks of enrollment)
- Number of grade 3 to 5 clinical adverse events or serious adverse events(within two weeks of enrollment)
- Cost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy.(24 weeks)
- Number of patients that will survive in the 24-week period.(24 weeks)