Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 6
- 主要终点
- Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy
研究概览
简要总结
In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.
详细描述
The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI. The study showed almost all children to have some degree of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major mutation.
After the study, the patients were managed based on the physician's judgment using genotyping results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.
- No viral resistance
- Low grade resistance with or without clinical/ immunological failure
- High grade resistance with or without clinical/ immunological failure.
There are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results
There are also new mutations that are not considered major mutation that may affect treatment outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children from HIV-NAT 013 phase I
排除标准
- •No inform consent obtained
结局指标
主要结局
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy
时间窗: 1 time point (Cross Sectional Study)
次要结局
- Comparison outcome of children in the 3 groups,(1 time point)
- Changes of mutation in children within the 3 groups, and(1 time point)
- Effect of previously unreported mutations, minor and others, on treatment outcome(1 time point)