ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
It is unclear whether children with HIV and severe acute malnutrition can be started on highly active antiretroviral therapy (HAART) safely while they are still malnourished and the manner in which this therapy should start. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected about to start on HAART for the first time
- •6-59 months old
排除标准
- •also being treated for TB
- •other chronic illness (e.g., congenital heart disease, cerebral palsy)
研究组 & 干预措施
Kwashiorkor
HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.
干预措施: zidovudine, lamivudine, nevirapine (Drug)
Marasmus
HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.
干预措施: zidovudine, lamivudine, nevirapine (Drug)
Control
HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason.
干预措施: zidovudine, lamivudine, nevirapine (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 6 weeks
PK of ART in malnourished children
次要结局
未报告次要终点