An Observational Multi-cohort Study on the Use of Fosamprenavir-Ritonavir Among HIV-infected Children and Adolescents in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Number of children on licensed dose of FPV/RTV
研究概览
简要总结
Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events were the most commonly reported AEs, but that the majority of events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was reported in 20% of children in the APV20003 trial; and neutropenia was identified as a potential safety concern by the European Medicines Agency (EMEA). The objectives of this study were to conduct an observational cohort study of the usage and safety of FPV/RTV in children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).
详细描述
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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-1 infected children aged 6-18 years exposed to licensed paediatric dose of FPV/RTV January 1 2008 (or date of exposure to FPV if earlier to this but still exposed at 1/1/2008) from the participating cohorts
排除标准
- 未提供
研究组 & 干预措施
HIV-1 infected children aged 6 ≤ 18 years
HIV-1 infected children aged 6 ≤ 18 years currently or having ever been exposed to FPV/RTV; this is the indicated group for the licensed dose in the paediatric population.
干预措施: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV) (Drug)
结局指标
主要结局
Number of children on licensed dose of FPV/RTV
时间窗: Assessed at 1, 2 and 3 years post exposure
次要结局
- Reason for stopping FPV(Assessed at 1, 2 and 3 years post exposure)
- Laboratory tests for absolute neutrophil counts (ANC), lipids (total cholesterol [TC] and triglycerides [TG]), and alanine transaminase (ALT)(Assessed at 1, 2 and 3 years post exposure)