Clinical Relevance of Nevirapine Resistance
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Virologic suppression at 6 months after randomization
研究概览
简要总结
This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).
详细描述
The wide use of NVP in pMTCT-prophylaxis may result in resistance to NNRTI and concomitantly limits the use of these drugs for the treatment of HIV-infected children. To avoid restricting treatment options for children, it is desirable to preserve NVP for both pMTCT and first line treatment. This study will therefore test whether resistance-caused treatment failures of HIV-infected and previously NVP-exposed children can be avoided if the NVP treatment is preceded by an initial PI-based regimen.
Comparison: HIV-infected children less than 24 months of age, exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups: (1) to continue on PI-containing regimen or (2) to be switched off the PI-containing regimen onto the NVP-containing regimen. The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization.
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
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NVP-exposure as part of pMTCT-prophylaxis around delivery
- •HIV-positive
- •Eligible for treatment
- •Plans to stay in the area for the next 6 months
排除标准
- •Already on anti-retroviral treatment
- •History of toxicity to perinatal NVP
- •Grade 3 or greater elevation of liver function tests
- •Being treated for a severe acute opportunistic infection or tumor
结局指标
主要结局
Virologic suppression at 6 months after randomization
次要结局
- To compare the time to virologic failure up to 18 months post randomization
- to examine the associations between detection of drug resistance mutation and virologic response to treatment
- to compare the toxicity profiles and adherence in the two groups
- to describe the emergence of genotypic resistance in the two groups