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CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in ART-naive and Treatment-experienced Viraemic Children and Adolescents Living with HIV in Africa

Project description

Tailoring HIV treatment for the youngest patients

Despite global progress, children and adolescents living with HIV (CALHIV) still face late diagnoses, high treatment failure rates, and avoidable deaths, particularly in sub-Saharan Africa. Treatment approaches often neglect this group, focussing instead on adult-centred innovations and neglecting younger patients. With this in mind, the EU-funded CHAPAS-5 project is running a clinical trial in Mozambique, Uganda and Zimbabwe to test personalised antiretroviral therapies (ART) tailored to children’s age, treatment history, and resistance patterns. Using an adaptive trial design, it evaluates both oral and injectable treatments, with social science and community engagement built in. CHAPAS-5 hopes to improve outcomes for CALHIV, shape future clinical guidelines, and bolster local health systems.

Objective

The 2.5 million children and adolescents living with HIV (CALHIV), most residing in sub-Saharan Africa, have unacceptably high rates of late diagnosis, treatment failure and death, compared to their adult counterparts. CALHIV are a vulnerable group who have been left behind adults in testing new treatment options, different modes of ART delivery, novel diagnostics and adherence strategies.
The CHAPAS-5 trial is a sustainable multi-country adaptive platform trial in Mozambique, Uganda and Zimbabwe, to assess novel treatment regimens in ART-naïve and treatment-experienced viraemic children aged 4 weeks to <20 years of age. CHAPAS-5 employs an innovative Personalised Randomised Controlled Trial (PRACTical) design, randomising participants between appropriate ART regimens based on their clinical status, ART history, genotypic resistance and drug availability by weight band. The trial's primary outcome is: alive with viral load <400 c/mL at 48 weeks. CHAPAS-5 will evaluate novel oral and first generation long-acting injectable (LAI) treatment regimens and, subsequently, through its adaptive design, second-generation promising long-acting therapeutics.
Nested pharmacokinetics will evaluate dosing for children, as needed. Social science, health economics and capacity strengthening are fully integrated through the project. Workpackages will explore options for community-delivery of LAIs, and employment of diagnostics, including POC CD4, near-POC viral load and resistance tests. Community groups and young people will be involved in our dissemination and communication activities. We will exploit project outputs and facilitate technology transfer for treatments and diagnostics from innovators to African manufacturers.
CHAPAS-5 aims to improve health and well-being of CALHIV, to inform clinical guidelines, and to strengthen health systems through capacity development. Our trial platform will provide a long-term resource for studies seeking to improve outcomes in CALHIV.

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2024-01-two-stage

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Coordinator

UNIVERSITY COLLEGE LONDON
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 2 245 464,00
Address
GOWER STREET
WC1E 6BT LONDON
United Kingdom

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 2 245 464,00

Participants (9)

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