A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 14
- 主要终点
- Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
研究概览
简要总结
This study will evaluate T-20 in children.
详细描述
Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 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 Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
时间窗: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
次要结局
- Number of Participants Who Died(Up to Week 96)
- Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)(Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1))
- Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide(Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1))
- Number of Participants Who Prematurely Withdrew Due to AE(Up to Week 96)
- Number of Participants With Worst Local Injection Site Reactions(Up to Week 96)
- Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)(Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1))
- AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)(Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1))
- Number of Participants With Adverse Events (AEs) and Serious AEs(Up to Week 4 after discontinuation of therapy)
- Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities(Up to Week 96)