Squillace, Nicola
Ricci, Elena Delfina
Orofino, Giancarlo
Forcina, Gabriele
Albini, Laura
Menzaghi, Barbara
De Socio, Giuseppe Vittorio
Piconi, Stefania
Maggi, Paolo
Madeddu, Giordano
Pellicanò, Giovanni Francesco
Sarchi, Eleonora
Celesia, Benedetto Maurizio
Lagi, Filippo
Salomoni, Elena
Di Biagio, Antonio
Bonfanti, Paolo
Funding for this research was provided by:
Gilead Sciences
Article History
Received: 27 February 2025
Accepted: 7 May 2025
First Online: 27 May 2025
Declarations
:
: The SCOLTA Project was conducted in accordance with the Declaration of Helsinki. The ethical approval was originally obtained by the Ethics Committee of the L.Sacco Hospital, where the principal investigator (dr. Rizzardini) was working at the time. Amendments were requested in 2013, 2019, 2020 and 2023: with this last amendment, the role of Principal Investigator was taken by dr. Bonfanti (IRCCS San Gerardo Monza), and the reference Ethics Committee changed. The original study protocol was approved on 18 September 2002, and three amendments were approved on 13 June 2013, 20 December 2019, 12 May 2020 and 12 June 2023 by the coordinating center at Hospital “L. Sacco”-University of Milan, Milan (Italy), and thereafter by all participating centers. Written consent for study participation was obtained from all participants, and the study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments and by Italian national laws. All patients starting one of the drugs included in the surveillance program in participating centers are consecutively asked to participate in the study after signing a written informed consent.
: N.S. received grants for educational activity, speaker’s fee, advisory board, research projects and for conferences’attending by Gilead Sciences and speaker’s fee and grant for attending conferences by ViiV Healthcare. P.M. received: Grant for publication, Advisory board fees, Conference hospitality: Gilead Science; Advisory board fees: ViiV Healthcare; Advisory board fees, Conference hospitality: MSD, Advisory board fees, Conference hospitality: Janssen. P.B. received advisory board fees by Viiv, Gilead, MSD and AstrazenecaB.M.C. reported honoraria for presentations and scientific advice from Gilead Sciences, ViiV Healthcare, Janssen‐Cilag, Mylan, GSK vaccines and Merck Sharp & Dohme and researchgrants for his institution from Gilead Sciences, ViiV Healthcare GSK vaccines and Merck Sharp &and Dohme. G.V.D.S. received speaker’s fees from Gilead Sciences and ViiV HealthcareF. Lparticipated on advisory boards sponsored by ViiV Healthcare, Janssen and recevide research grant from Gilead A.D.B. has received speakers’ honoraria from Gilead, ViiV and Janssen-Cilag, has been an advisor for ViiV, Gilead and MSD, and has received grant for research from Gilead Sciences and ViiV healthcare.All the other authors declared no conflicts of interests.