Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 4
- 主要终点
- Initial therapeutic cohort: Virological success
研究概览
简要总结
The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily.
The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.
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
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
arm 1 (reference strategy)
AZT-3TC-LPV/r twice a day
干预措施: AZT-3TC-LPV/r twice a day (Drug)
arm 2 (simplification strategy)
ABC-3TC-EFV once a day
干预措施: ABC-3TC-EFV once a day (Drug)
结局指标
主要结局
Initial therapeutic cohort: Virological success
时间窗: 12 months
survival without virological failure (death or loss of follow-up or virologic failure, i.e. HIV-ARN ≥400 copies/mL on one consecutive sample), analysis of resistance profile.
Randomised simplification phase: Virological success
时间窗: 25 months
survival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25.
次要结局
- Virological success(12 months)
- Immunological response(12 and 25 months)
- Antiretroviral and cotrimoxazol pharmacokinetic parameters(6, 19 and 25 months)
- Tolerance(12 and 25 month)
- Adherence(12 and 25 months)
- Resistance to antiretroviral(12 and 25 months)