The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- pharmacokinetics of atazanavir/ritonavir (ATV/r)
研究概览
简要总结
There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children. Therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.
详细描述
Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART have been commonly prescribed as the first-line HAART for HIV-infected children in resource-limited settings. Protease inhibitor (PI)-based HAART are the recommended second-line regimen after failing NNRTI-based HAART. The most commonly used PI in Thailand is lopinavir/ritonavir (LPV/r). However, the metabolic complications of lopinavir/ritonaive (LPV/r) such as hyperlipidemia and lipodyrtrophy are common and a concern for HIV-infected children as it may contribute to the development of cardiovascular disease in the longer term. There are data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected adults but none in children. Furthermore, many studies in both adults and children have shown that different ethnicities can result in different pharmacokinetic response to antiretroviral drugs. As a result of this, this study investigated the efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected children
- •Age from 6- 18 years old
- •Body weight ≥ 25 kg at screening visit
- •ARV history, the children can be categorized in one of these 2 groups
- •ALT <200 IU/L at screening visit
- •Total bilirubin < 3 mg/dL at the screening visit
- •Can swallow capsule
- •Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)
排除标准
- •Active opportunistic infection
- •Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.
- •Use of concomitant medication that may interfere with the pharmacokinetics of ATV/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.)
- •Pregnancy or lactating at screening visit
- •Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis
- •Inability to understand the nature and extent of the study and the procedures required.
研究组 & 干预措施
PI-experience group
Using PI-based HAART for ≥6 months at the screening visit HIV-RNA viral load < 50 copies/ml at the screening visit No history of HIV-RNA ≥ 1,000 copies/ml while using PI-based HAART
干预措施: boosted atazanavir (ATV/r) (Drug)
PI-naïve group
Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit
干预措施: boosted atazanavir (ATV/r) (Drug)
结局指标
主要结局
pharmacokinetics of atazanavir/ritonavir (ATV/r)
时间窗: 48 weeks
Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed
次要结局
- plasma viral load (HIV RNA)(48 weeks)
- hyperbilirubin(48 weeks)
- CD4(48 weeks)