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
- 4
- 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
- •Male or female patients between 3 months and 16 years of age at day 28 of the study.
- •Evidence of HIV-1 infection
- •Patients who are antiretroviral drug naive
- •Plasma viral load detectable
- •CD4 >=50 cells/cc3
- •Written informed permission
- •Active assent given by the patient if the child is capable of understanding the given information
- •Reasonable probability for completion of the trial
排除标准
- •Any significant disease, other than HIV
- •Any acute illness within 2 weeks prior to Day 0
- •Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
- •Patients requiring systematic treatment with CYP3A4 substrates
- •Patients with malabsorption, severe chronic diarrhea
- •Receipt of any cytotoxic therapy for malignancy
- •Current grade 3 or 4 clinical or laboratory toxicity
- •Pregnancy or breast-feeding
- •Females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse
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
- Treatment Failure(48 weeks)
- Virologic Response(48 weeks)
- Virologic Failure(48 weeks)
- Time to Virologic 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)