CHAPAS-5: an adaptive platform trial for evaluation of novel treatment regimens in children and adolescents with HIV in Africa

University College London0 个研究点目标入组 800 人开始时间: 2026年11月30日最近更新: 2026年8月10日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized
干预模型: Pragmatic open-label adaptive platform trial using the PRACTical design
主要目的: Treatment
盲法: None

•Aged =4 weeks to <15 years* with confirmed HIV infection
•Weight =3 kg and <30 kg*
•Written informed consent obtained (and assent if applicable)
•Willing to adhere to a minimum of 48 weeks' follow-up
•*Upper limits of 15 years and 30 kg are for initial treatment options and may be amended when further treatment options are introduced (through a protocol amendment)
•If antiretroviral therapy (ART)-naive:
•Planning to start first-line ART
•Virologically unsuppressed with viral load (VL) =400 copies/ml at screening
•If ART-experienced:
•ART-experienced and on DTG-based ART and have been on DTG-based ART for at least 6 months prior to screening
•Virologically unsuppressed for at least 3 months, demonstrated by two consecutive VLs =400 copies/ml in the last year; the second VL must be at screening
•Received adherence counselling as per standard practice prior to screening

•Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR both ALT =3 x ULN and bilirubin =2 x ULN at screening**
•Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
•Severe renal impairment, defined as creatinine clearance <30 mL/min/1.73 m², at screening**
•Severe life-threatening illness (not expected to survive beyond two weeks) as determined by the investigator's clinical judgement
•Eligible for less than two permitted treatment options based on tables 3 (ART-naive participants) and 4 (ART-experienced participants)
•Concurrent participation in another clinical trial of an investigational medicinal product (IMP), medical device or other intervention

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