HIV

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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Simultaneous pharmacokinetic modeling of unbound and total darunavir with ritonavir in adolescents: a substudy of the SMILE trial

2023

Authors: Abdalla S, Compagnucci A, Riault Y, Chan KM, Bamford A, Nolan A, Ramos TJ, Constant V, Nguyen T, Zheng Y, Tréluyer J, Froelicher-Bournaud L, Neveux N, Saidi Y, Cressey RT, Hirt D on behalf of the SMILE study group

Published in: Antimicrobial Agents and Chemotherapy

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The UNIVERSAL project’s potential impact on the health of children living with HIV, told by Dr Vivian Mumbiro

2023

In recent years, advancements in medical research have paved the way for an array of treatment options for children living with HIV. The efforts of scientists and researchers globally, have led to continuous refinement and improvement of existing regimens. Dr. Vivian Mumbiro, affectionately known as Dr V, a dedicated Medical Officer at the University of Zimbabwe Clinical Research Centre, shares insights into the evolving landscape of paediatric HIV treatment.

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Advancements in paediatric HIV research: Insights from the EPIICAL general assembly meeting 

2023

In the quest to enhance our understanding of paediatric HIV and improve treatment outcomes, the EPIICAL project has worked tirelessly for the past eight years to gather and generate knowledge on HIV in children. Established with the ambitious goal of creating models to predict how children’s bodies respond to early antiretroviral therapy (ART) and treatment interruption, the EPIICAL project has also aimed to refine methods for understanding immune,

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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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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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D3 trial completes recruitment ahead of schedule!

2023

The D3 trial is excited to announce that it has successfully completed recruitment in the trial at an exceptional speed. D3 is looking to see if a new tablet, a combination of two anti-HIV medicines, dolutegravir (DTG) and lamivudine (3TC), is as good and effective in treating HIV in children and young people living with HIV in comparison to the current paediatric anti-HIV medicines available.

The trial recruited 370 children from South Africa,

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The Smooth Away From Expected (SAFE) non-inferiority frontier: theory and implementation with an application to the D3 trial

2023

Authors: Quartagno, M, Chan, M, Turkova, A et al.

Published in: Trials

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Sensitive HIV-1 DNA Pol Next-Generation Sequencing for the Characterisation of Archived Antiretroviral Drug Resistance

2023

Authors: Botha JC, Byott M, Spyer MJ, Grant PR, Gärtner K, Chen WX, Burton J, Bamford A, Waters LJ, Giaquinto C, et al.

Published in: Viruses

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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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Penta hosts workshops on long-acting injectable antiretrovirals for children and adolescents  

2023

Between the months of April and May 2023, Penta hosted advisory group meetings where young people between the ages of 15 and 19 from South Africa, Argentina, the United Kingdom and Thailand, were invited to share their experiences and knowledge of long-acting injectable antiretrovirals at local in-person consultation workshops. The young people all had recent experience in paediatric HIV care and joined in the discussions about the acceptability, challenges and solutions of adopting and using long-acting injectables for themselves and their peers and how this could support or impact their transition to adult care.

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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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World AIDS Day 2022: Is HIV cure attainable in our lifetime?

2022

In the lead-up to #WorldAIDSDay2022, people wonder, is an HIV cure attainable in our lifetime?

Yes, we believe there are good reasons to be optimistic about a cure:

  • The advances in treatment
  • Better access to therapy
  • Early initiation of effective antiretroviral treatment
  • Increasing numbers of children living with HIV who are surviving into adolescence and beyond
  • Reported cases of people living with HIV with a viral reservoir to a level that allowed maintenance of remission even after treatment interruption.
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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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The Development of Quality Standards for the ethical and meaningful participation of children and young people in clinical trials and research

2022

Authors: Burke, T; Conway, M

Presented at: AIDS 2022 an the International Workshop on HIV & Adolescence 2022

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