paediatrics

CARMA Global study hits recruitment target

2023

The CARMA Global study, part of the EPIICAL project, has successfully met its recruitment target and recruited 99 children and adolescents living with HIV from across the globe. The study includes children and adolescents who acquired HIV around the period of their birth and then started antiretroviral therapy (ART) at a young age to control the virus and prevent its progression.

The primary aim of CARMA Global is to investigate how the body responds to HIV and how the virus is stored and behaves in the body over time.

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Prediction of C-reactive protein dynamics during meropenem treatment in neonates and infants

2023

Authors: Soeorg H, Padari H, Ilmoja M-L, Herodes K, Kipper K, Lutsar I, Metsvaht T, NeoMero Consortium

Published in: British Journal of Clinical Pharmacology

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What explains the poor contraction of the viral load during paediatric HIV infection?

2023

Authors: Schröter J & De Boer R

Published in: Journal of Theoretical Biology 2023

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What to expect at a PK study day

2023

A new animated video aimed at study participants explains what happens during a pharmacokinetics (PK) study. The video, which is now available to watch online in Lugandan, Isizulu and English, can be used to inform patients taking part in a range of future studies across different disease areas.

PK studies look at how medicines move in, through and out of the body.

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Effect of dolutegravir on folate, vitamin B12 and mean corpuscular volume levels among children and adolescents with HIV: a sub-study of the ODYSSEY randomized controlled trial 

2023

Authors: Barlow-Mosha L.N., Ahimbisibwe G.M., Chappell E., Amuge P.M., Nanduudu A., Kaudha E., Amukele T., Balamusani D., Kafufu B., Nimwesiga A., Kataike H., Namwanje R., Kasangaki G., Mulindwa A., Muzorah, G.A., Bbuye D., Musiime V., Mujyambere E., Ssenyonga M., Mulima D., Kyambadde R.C., Namusanje J., Isabirye R., Nabalamba M., Nakirya B.M., Kityo C., Kekitiinwa A.R., Giaquinto, C., Copp A., Gibb, D.M., Ford, D., Musoke P., Turkova A

Published in: Journal of the International AIDS Society

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Relative bioavailability of dolutegravir (DTG) and emtricitabine/tenofovir alafenamide fumarate (F/TAF) administered as paediatric tablet formulations in healthy volunteers 

2023

Authors: Bevers LAH., Kamphuis AEM., van der Wekken-Pas LC, Leisegang R, Lewis L, Burger DM, Colbers A

Presented at: International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs 2023

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Gilead partners with CHAI and Penta to improve treatment and adherence rates among children with HIV in low and middle income countries

2023

FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) is pleased to announce two public-private partnerships. The first will accelerate the development of an investigational dispersible pediatric formulation containing emtricitabine and tenofovir alafenamide (F/TAF). The second aims to develop investigational pediatric formulations of TAF and sofosbuvir (SOF) designed to eliminate bitterness.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment,

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SMILE once-daily regimen non-inferior to triple ART regimen

2023

Findings from the Strategy for Maintenance of HIV suppression with integrase inhibitor + darunavir/ritonavir in children (PENTA-17) trial, simply known as SMILE, were published in eClinicalMedicine on 2 June 2023. SMILE is the first randomised trial to determine whether children living with HIV on ART with suppressed viral load could maintain the suppression on a once-daily regimen compared to the standard of care (SOC) which involves three ART drugs. 

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Inaugural training session for UNIVERSAL’s Clinical Trial Management course

2023

The inaugural Clinical Trial Management training program took place online on Wednesday, 14 June 2023, after 428 participants registered. The session was well attended by up to 168 clinical trial staff representing 30 countries. The training course is being implemented by UNIVERSAL’s Work package 8 and focuses on improving the capacity of research staff and young investigators to design, implement, and manage regulatory clinical trials, especially paediatric clinical trials.

This was the first module, 

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EPIICAL General Assembly meeting to reaffirm mission to achieve HIV remission in children

2022

The EPIICAL General Assembly was held online and in person in Venice on 2-4 November 2022. It brought together 80 participants from 29 organisations from the EPIICAL consortium. Attendees came together to discuss, among other topics, highlights of the project as a clinical and experimental platform to evaluate therapeutic strategies for HIV remission and/or cure in children, updates in the treatment and management of paediatric HIV and the vision for EPIICAL in 2024 and beyond.

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