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临床试验/PACTR201103000279108
PACTR201103000279108已完成未知

Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens

Medical Research Council0 个研究点目标入组 64 人开始时间: 2011年3月11日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
64

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
3 Month(s) 至 13 Year(s)(—)
性别
All

入选标准

  • 1) HIV infected infants aged 3 months to <12 months currently taking or about to start LPV/r syrup based first-line following WHO guidelines 2008 [7].
  • HIV infected children able to swallow paediatric LPV/r tablets and aged 4-13 years and <25Kg, currently taking or about to start LPV/r based second-line following WHO guidelines.
  • HIV infected infants aged 1 to 4 years currently taking or about to start LPV/r syrup based first-line
  • 2. Carers, and children where appropriate, willing and able to give informed consent

排除标准

  • 1. Who are expected to change weight bands (i.e. change dose) after enrolment and before PK day at week 8
  • 2. With anaemia (haemoglobin <8.5g/dL), or liver enzymes grade 2 or higher.
  • 3. With illnesses that could influence the pharmacokinetics of the antiretroviral (ARV) drugs at week 4 and week 8 e.g. severe diarrhoea, vomiting, renal or liver disease
  • 4. On concomitant medications that are known to interact with the ARV drugs

研究者

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