Children with HIV in Africa – pharmacokinetics and acceptability of simple second-line antiretroviral regimens (CHAPAS-4 trial): a randomised controlled trial

niversity College London (UK)0 个研究点目标入组 919 人开始时间: 2017年10月20日最近更新: 2024年5月21日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 919

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37280040/ Pharmacokinetic substudy secondary outcome results (added 07/06/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37315296/ Substudy results (added 15/06/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37471330/ Substudy results (added 21/07/2023)

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Current inclusion criteria as of 17/07/2019:
•1. HIV-infected currently receiving NNRTI containing regimen with abacavir-, zidovudine- or stavudine-containing NRTIbackbone and failing according to current WHO criteria:
•1.1. Confirmed VL >1000 copies/ml after adherence counselling (confirmatory may be at screening) OR
•1.2. CD4 criteria for failure OR
•1.3. Clinical criteria for failure
•2. Aged 3-15 years inclusive
•3. Weight 14 kg or higher
•4. Viral load >400 copies/ml at screening visit
•5. Able to swallow trial drug tablets (all children will have been receiving tablets within first-line ART)
•6. If female and reached menses, then negative pregnancy test at screening (and randomisation if randomisation >2 weeks from screening) and willing to adhere to highly effective methods of contraception if sexually active
•7. Parents/carers give informed written consent; child provides informed written assent as appropriate based on age, knowledge of HIV status and local country guidelines
•Previous inclusion criteria:
•1. HIV-infected failing first-line treatment with abacavir-, zidovudine- or stavudine-containing NRTI+NNRTI regimens as per current WHO criteria
•2. Aged 3-15 years inclusive
•3. Weight 14 kg or higher
•4. Viral load >400 copies/ml at screening visit
•5. Able to swallow trial drug tablets (all children will have been receiving tablets within first-line ART)
•6. Parents/carers give informed written consent; child provides informed written assent as appropriate based on age, knowledge of HIV status and local country guidelines

排除标准

•Current exclusion criteria as of 17/07/2019:
•1. History or presence of known allergy or other contraindication to the study drugs or their components
•2. Treatment of co-morbidities, except TB, with significant drug interactions with the study drugs, requiring their dose adjustment
•3. Breastfeeding
•4. More than 3 months (>91 days) from the screening visit
•5. Evidence of previous failure on LPV/r
•6. Evidence of previous failure on both abacavir and zidovudine
•7. Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR ALT =3xULN and bilirubin =2xULN
•8. Patients with 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)
•Previous exclusion criteria:
•1. History or presence of known allergy or other contraindication to the study drugs or their components
•2. Treatment of co-morbidities, except TB, with significant drug interactions with the study drugs, requiring their dose adjustment
•3. More than 3 months (>91 days) from the screening visit

研究者

发起方

niversity College London (UK)

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