Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- AUC of abacavir after qd and bid dosing
研究概览
简要总结
Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with definitive HIV infection
- •Age > 2 and < 13 years
- •Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.
排除标准
- •• Intercurrent illness
- •Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
- •Abnormal renal or liver function (grade 3 or above)
研究组 & 干预措施
Twice daily
干预措施: ABC Twice Daily (Drug)
Twice daily
干预措施: 3TC Twice Daily (Drug)
Once daily
干预措施: ABC Once Daily (Drug)
Once daily
干预措施: 3TC Once Daily (Drug)
结局指标
主要结局
AUC of abacavir after qd and bid dosing
时间窗: week 0 and week 4
Cmin of abacavir after qd and bid dosing
时间窗: week 0 and week 4
Cmax of abacavir after qd and bid dosing
时间窗: week 0 and week 4
Area Under Curve (AUC) of lamivudine after qd and bid dosing
时间窗: week 0 and Week 4
Cmin of lamivudine after qd and bid dosing
时间窗: week 0 and week 4
Cmax of lamivudine after qd and bid dosing
时间窗: week 0 and week 4
次要结局
- To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens(Week 0 and week 4)