A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 6
- 主要终点
- Area under the concentration-time curve over one dosing interval (AUCτ)
研究概览
简要总结
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.
详细描述
A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.
Primary objective: To evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 in antiretroviral drug naive pediatric patients.
Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment
Study Hypothesis:
Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. The goal in this study was to determine if a Nevirapine suspension dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.
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 16 Years（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
结局指标
主要结局
Area under the concentration-time curve over one dosing interval (AUCτ)
时间窗: 1, 3 and 6 hours on Day 28
Maximum observed concentration (Cmax)
时间窗: 1, 3 and 6 hours on Day 28
Minimum observed concentration (Cmin)
时间窗: 1, 3 and 6 hours on Day 28
Oral clearance (Dose/AUC) at steady state
时间窗: 1, 3 and 6 hours on Day 28
次要结局
- Virologic Response(48 weeks)
- Virologic Failure(48 weeks)
- Time to Virologic Failure(48 weeks)
- Treatment Failure(48 weeks)
- Time to Treatment Failure(48 weeks)
- Occurrence of Rash(48 weeks)
- Time to Virologic Suppression(48 weeks)
- Occurrence of Adverse Events(48 weeks)
- Change in HIV-1 RNA count(week 2, 4, 8, 12, 18, 24, 30, 36, 42,48)
- Change in CD4+ percent(week 2, 4, 8, 12, 18, 24, 30, 36, 42,48)
- Change in CD4+ cell count(week 2, 4, 8, 12, 18, 24, 30, 36, 42,48)