Hentzien, Maxime
Bonnet, Fabrice
Bernasconi, Enos
Biver, Emmanuel
Braun, Dominique L.
Munting, Aline
Leuzinger, Karoline
Leleux, Olivier
Musardo, Stefano
Prendki, Virginie
Schmid, Patrick
Staehelin, Cornelia
Stoeckle, Marcel
Walti, Carla S.
Wittkop, Linda
Appay, Victor
Didierlaurent, Arnaud M.
Calmy, Alexandra
Funding for this research was provided by:
University of Geneva
Article History
Received: 14 February 2024
Accepted: 5 March 2024
First Online: 19 March 2024
Declarations
:
: This trial has received ethical approval from the Geneva Cantonal Commission for Ethics and Research (CCER - BASEC 2022 − 01314) on 20 October 2022, and by the relevant ethics commissions: Kantonale Ethikkommission Bern (14 November 2022), EKNZ (Ethikkommission Nordwest- und Zentralschweiz, 20 November 2022), EKOS (Ethikkommission Ostschweiz, 2 November 2022), Ethikkommission Tessin (24 November 2022), Commission cantonale d’éthique de la recherche sur l’être humain CER-VD (8 November 2022) and Ethikkommission Zürich (1 November 2022). In France the protocol has been approved by the “Comité de Protection des Personnes” and by the “Agence nationale de sécurité du medicament et des produits de santé” on July 20, 2023. The study will be conducted in accordance with the Declaration of Helsinki and with each country’s laws and regulations, as well as with Guidelines for Good Clinical Practice for biomedical research on drugs for human use and ICH Good Clinical Practice E6 (R2) 9 November 2016, European Regulation EU no. 536/2014, and Good Clinical Laboratory Practice (World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases, 2009). Participants must provide signed and dated written informed consent prior to undergoing any study-specific procedure. Participants will have the opportunity to provide consent for the use of health-related data and samples for research purposes.
: Not applicable.
: DLB reports honoraria for advisory boards payed to himself from the companies AstraZeneca, Gilead, MSD, Pfizer and ViiV. ADM reports honoraria for participation to scientific advisory boards of Speransa, Bioaster, Sanofi, to Data Safety Monitoring Board for AMC Biosciences and speaker bureau for Roche and Merck. All the other authors declare that they have no competing interests.