Clinical trials

The c4c project, co-coordinated by Penta together with Janssen, Bayer and the University of Liverpool, has had its first review, titled “European research networks to facilitate drug research in children”, published by the British Journal of Clinical Pharmacology.  We are proud to have the Penta_ID Network involved in such an impactful project as a speciality network.

This review discusses the need for a structured approach to drug development by establishing and utilizing research networks and infrastructure.

Author: Mark A. Turner, Katharine Cheng, Saskia de Wildt, Heidrun Hildebrand, Sabah Attar, Paolo Rossi, Donato Bonifazi, Adriana Ceci, Joana Claverol, Begonya Nafria, Carlo Giaquinto

Published in: British Journal of Clinical Pharmacology

Abstract: Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summarises recent efforts to overcome these barriers in Europe.

Last Patient Last Visit (LPLV) completed for the Penta 17 Strategy for Maintenance of HIV suppression with integrase inhibitor + darunavir/ritonavir in children (SMILE) trial.

The Penta sponsored trial, SMILE, has completed its last patient last visit. This exciting news comes to us following the closure of patient enrolment for SMILE last year, where all participants recruited were followed up for a minimum of 48 weeks until the last participant enrolled reached 48 weeks of follow-up on 11 August 2020.

Clinical Trials Day is a well-deserved ‘time out’ to recognize the people who conduct clinical trials and to say “thanks” for what they do every day to improve public health.

Authors: Hill LF, Turner MA, Lutsar I, et al; NeoVanc Consortium.

Published in: Trials. 2020;21(1):329

Authors: Folgori L, Lutsar I, Standing JF, et al.

Published in: BMJ Open. 2019; 9:e032592

c4c (conect4children) is a large collaborative European network that aims to facilitate the development of new drugs and other therapies for the entire paediatric population.

The voices of children, young people and their families are a pivotal part of the c4c project. It places patients at the centre and will assign them an active role in the development of the different clinical trials that are going to be carried out during this project.

The Penta-sponsored clinical trial SMILE has achieved a significant milestone by recruiting its 100^th patient yesterday. The patient was enrolled at the Perinatal HIV Research Unit (PHRU) in Soweto, South Africa. This is a wonderful result achieved through hard work and cooperation among the sites, the CTUs and the sponsor.

SMILE (also known as PENTA 17) stands for “Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor + darunavir/ritonavir in childrEn”

We are pleased to announce that enrollment in the SMILE study has recommenced. 3 new participants have recently been recruited in the clinical trial: 2 in Porto, Portugal and 1 in Zurich, Switzerland.

SMILE is a multicentre randomised study evaluating safety and antiviral effect of a once daily integrase inhibitor administered with Darunavir/Ritonavir compared to standard of care among HIV-1 infected, virologically suppressed paediatric participants.

PENTA is sponsor of this study,

The EU funded project PREPARE has released a communication brief updating stakeholders on the project activities related to this season’s influenza activity.

A press release has also been published with more information about the exciting and innovative PREPARE’s ALIC4E clinical trial. This is the only study that is currently randomizing patients to receive antiviral treatment or not.