Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Criteria for switching HIV-Infected Children to second line
研究概览
简要总结
The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children randomized to two switching criteria.
详细描述
The overall goal of the study was aimed at determining whether the use of the current WHO criteria alone (clinical and immunologic) to define treatment failure as the trigger for switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month treatment outcomes when compared to combining clinical and immunologic parameters with viral load (VL) monitoring.
In addition the study aimed at obtaining plasma samples from treatment experienced children, for future resistance testing. The results of this study may help guide WHO and national pediatric ART programs on the need for routine VL monitoring for children initiating HAART in resource limited settings, where virologic tests including resistance testing are not readily available or affordable.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-Infected Children, 1 year to 12 years
- •ART experienced and enrolled in an existing treatment program that used clinical and immunologic criteria to monitor response to ART.
排除标准
- 未提供
结局指标
主要结局
Criteria for switching HIV-Infected Children to second line
时间窗: 2 years
Confirmed viral load \> 1,000 HIV RNA copies/ml
次要结局
未报告次要终点