Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,177
- 试验地点
- 1
- 主要终点
- Mortality rate among HIV patients with advanced disease
研究概览
简要总结
CRICS financial report for the first budget year of the study
详细描述
Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Aged ≥ 18 years
- •Confirmed HIV infection using National Testing Algorithm
- •CD4 ≤100 cells/μL
- •Able to provide written informed consent
排除标准
- •History of prior CM
- •Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
- •Currently taking ART or history of ART for more than 4 weeks within the past year
- •Known to be currently pregnant or planning to become pregnant during the study period
研究组 & 干预措施
Assigned Interventions Antifungals Patients with symptoms
Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management.
For CrAg-positive patients, the initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 >200 cells/µL for at least 6 months.
干预措施: Vietnam Cryptococcal Retention in Care Study (CRICS) (Other)
结局指标
主要结局
Mortality rate among HIV patients with advanced disease
时间窗: 12 months
The proportion of patients who have advanced HIV disease (CD4 <100)
时间窗: 12 months
Prevalence of CrAg-positivity among HIV patients with advanced disease
时间窗: 12 months
The proportion of patients who have no new opportunistic infections at 12 months
时间窗: 12 months
次要结局
- The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months(Up to 12 months)
研究者
Vu Quoc Dat
Lead Coordinator
National Hospital for Tropical Diseases, Hanoi, Vietnam