Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS-2): an open, randomised, controlled, phase I, crossover trial

Medical Research Council (UK)0 个研究点目标入组 40 人开始时间: 2011年4月28日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Human immunodeficiency virus (HIV) infected infants aged 3 months to < 12 months currently taking or about to start Lopinavir/ritonavir (LPV/r) syrup based first-line following WHO guidelines 2008 [7] or
•2. 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
•2. Carers and children where appropriate, willing and able to give informed consent

•1. Who are expected to change weight bands (i.e. change dose) after enrollment 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

发起方

Medical Research Council (UK)