HIV

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

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,

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,

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.

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. 

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, 

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.

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.

Authors: Burke, T; Conway, M

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

Authors: Cebekhulu, S; Shibemba, M; Conway, M; Kiganda, C; Ahimbisibwe, Bhiri, J; Carter, A; Ely, A; Gondo, S; Nkosi, N.

Presented at: AIDS 2022 and International Workshop on HIV & Adolescence 2022

Babies and young children treated with the anti-HIV drug dolutegravir, in combination with other anti-HIV drugs, are more likely to keep the virus under control, compared to those treated with standard anti-HIV treatment combinations. This is according to results from part of the ODYSSEY trial that were published yesterday in The Lancet HIV.

This is consistent with previous results from older children in the ODYSSEY trial,

CARMA Global is an EPIICAL cross-sectional, multi-country, multi-site, low interventional study on children, adolescents and youth who started ART at three months or younger at least seven years ago and are currently on ART. The study aims to investigate viral reservoirs in these populations to better understand why ART is more effective in some patients than in others. In the social component, the study will collect data on attitudes towards HIV research to develop strategies to keep participants enrolled in clinical trials.

Authors:Jacobs TG, Schouwenburg S, Penazzato M, Archary M, Ruel TD, van den Anker J, Burger DM, Cressey TR, Abrams EJ, Lyall H, Bekker A, Colbers A; Penta Clinical Pharmacology Working Group; PADO-HIV 5 participants.

Published in: The Lancet

Authors: Turkova A, Waalewijn H, Chan M, Bollen P, Bwakura-Dangarembizi M, Kekitiinwa A, Cotton M, Lugemwa A, Variava E, Ahimbisibwe MG, Srirompotong U, Mumbiro V,Amuge P, Zuidewind P, Ali S, Kityo C,Archary M, Ferrand R, Violari A, Gibb D,Burger D, Ford D, Colbers A, on behalf of the ODYSSEY Trial Team

Published in: The Lancet

Results from a substudy of the ODYSSEY trial show that children being treated for tuberculosis (TB) and HIV at the same time can safely have the anti-HIV medicine dolutegravir twice a day. These results were published yesterday in The Lancet HIV journal.

Around 50,000 children are co-infected with both TB and HIV each year. Treating the two diseases at the same time is complicated, as a commonly used TB drug,

A new trial opened in May, aiming to find out if children and young people living with HIV can take two anti-HIV medicines instead of three. The trial has already recruited 57 participants in Uganda and Thailand.

People living with HIV have to take medicines for life. Therefore, it is important to ensure that these medicines work well and continue to be safe to take for children and young people living with HIV.

The first two participants of the SHIELD trial (PENTA-22) were screened by Dr. Renate Strehlau and her team at Rahima Moosa Mother and Child Hospital, Johannesburg, South Africa in June 2022.  SHIELD is the first paediatric trial on Fostemsavir, targeting children living with HIV that have developed resistance to two or more antiretroviral drug classes.

SHIELD aims to evaluate the safety of fostemsavir when taken with optimized background antiretroviral therapy.

[vc_row][vc_column][vc_column_text]By design, capacity building is a fundamental part of the UNIVERSAL project. The aim of the project’s capacity building activities are to improve the ability of African and European young investigators in designing and conducting clinical trials. As such, the project conducted a Training Needs Assessment (TNA) from March 17^th to June 21^st 2021 among 108 African early career researchers from Cameroon, Mali, Senegal,