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16 results on '"Carleo M. A."'

2. People with HIV pioneers of injectable cabotegravir and rilpivirine long acting in Italy: who are they?

Author

Bartalucci, C, Baldi, F, Ricci, E, Orofino, G, Menzaghi, B, Ferrara, S, Pellicano', G, Squillace, N, Sarchi, E, Pontali, E, Cenderello, G, Bargiacchi, O, Piccica, M, Carleo, M, Cascio, A, De Socio, G, Bonfanti, P, Di Biagio, A, Bartalucci C., Baldi F., Ricci E., Orofino G., Menzaghi B., Ferrara S., Pellicano' G. F., Squillace N., Sarchi E., Pontali E., Cenderello G., Bargiacchi O., Piccica M., Carleo M. A., Cascio A., De Socio G. V., Bonfanti P., Di Biagio A., Bartalucci, C, Baldi, F, Ricci, E, Orofino, G, Menzaghi, B, Ferrara, S, Pellicano', G, Squillace, N, Sarchi, E, Pontali, E, Cenderello, G, Bargiacchi, O, Piccica, M, Carleo, M, Cascio, A, De Socio, G, Bonfanti, P, Di Biagio, A, Bartalucci C., Baldi F., Ricci E., Orofino G., Menzaghi B., Ferrara S., Pellicano' G. F., Squillace N., Sarchi E., Pontali E., Cenderello G., Bargiacchi O., Piccica M., Carleo M. A., Cascio A., De Socio G. V., Bonfanti P., and Di Biagio A.

Abstract

Injectable cabotegravir and rilpivirine long-acting therapy is a revolutionary new antiretroviral treatment (ART) option for HIV infection in virologically suppressed adults on a stable ART. The aim of this study from SCOLTA multicenter observational prospective database is to describe the first people living with HIV (PWH) who started this regimen in Italy, assessing adherence to eligibility criteria, describing clinical-epidemiological characteristics compared to registration trials-population and describe early treatment-discontinuations.

Published
2024

3. TD-1 Efficacy, safety and metabolic changes at 6-months after switch to long-acting injectable CAB/RPV: results from an observational prospective multicenter study

Author

Bartalucci, C, Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Pellicanò, GF, Carleo, MA, De Socio, GV, Bartalucci, C, Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Pellicanò, GF, Carleo, MA, and De Socio, GV

Published
2024

4. Low level viremia at the beginning and in course of long-acting treatment with injectable cabotegravir and rilpivirine

Author

Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Null, N, Pellicanò, GF, Carleo, MA, De Socio, GV, null, null, Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Null, N, Pellicanò, GF, Carleo, MA, De Socio, GV, and null, null

Published
2024

5. Lipids, weight gain and body mass index in ARV experienced PLWH treated with doravirine-based treatments: a comparison between dual or triple regimens vs bictegravir based triple regimen

Author

Masiello, A, Iodice, V, Menzaghi, B, Taramasso, L, Bellagamba, R, Molteni, C, Pellicanò, G, Squillace, N, Sarchi, E, Lagi, F, Cascio, A, Carleo, M, Celesia, B, Salomoni, E, Ferrara, S, Pontali, E, De Socio, G, Madeddu, G, Franzetti, M, Martini, S, Falasca, K, Orofino, G, Bargiacchi, O, Fiordelisi, D, Angioni, G, Cenderello, G, Calza, L, Di Biagio, A, Bonfanti, P, Maggi, P, Null, N, Pellicanò, GF, Carleo, MA, Celesia, BM, De Socio, GV, null, null, Masiello, A, Iodice, V, Menzaghi, B, Taramasso, L, Bellagamba, R, Molteni, C, Pellicanò, G, Squillace, N, Sarchi, E, Lagi, F, Cascio, A, Carleo, M, Celesia, B, Salomoni, E, Ferrara, S, Pontali, E, De Socio, G, Madeddu, G, Franzetti, M, Martini, S, Falasca, K, Orofino, G, Bargiacchi, O, Fiordelisi, D, Angioni, G, Cenderello, G, Calza, L, Di Biagio, A, Bonfanti, P, Maggi, P, Null, N, Pellicanò, GF, Carleo, MA, Celesia, BM, De Socio, GV, and null, null

Published
2024

6. Risk of Cardiovascular Events in People with HIV (PWH) Treated with Integrase Strand-Transfer Inhibitors: The Debate Is Not Over; Results of the SCOLTA Study

Author

Corti, N, Menzaghi, B, Orofino, G, Guastavigna, M, Lagi, F, Di Biagio, A, Taramasso, L, De Socio, G, Molteni, C, Madeddu, G, Salomoni, E, Pellicanò, G, Pontali, E, Bellagamba, R, Celesia, B, Cascio, A, Sarchi, E, Gulminetti, R, Calza, L, Maggi, P, Cenderello, G, Bandera, A, Carleo, M, Falasca, K, Ferrara, S, Martini, S, Guadagnino, G, Angioni, G, Bargiacchi, O, Ricci, E, Squillace, N, Bonfanti, P, Corti, Nicolò, Menzaghi, Barbara, Orofino, Giancarlo, Guastavigna, Marta, Lagi, Filippo, Di Biagio, Antonio, Taramasso, Lucia, De Socio, Giuseppe Vittorio, Molteni, Chiara, Madeddu, Giordano, Salomoni, Elena, Pellicanò, Giovanni Francesco, Pontali, Emanuele, Bellagamba, Rita, Celesia, Benedetto Maurizio, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Calza, Leonardo, Maggi, Paolo, Cenderello, Giovanni, Bandera, Alessandra, Carleo, Maria Aurora, Falasca, Katia, Ferrara, Sergio, Martini, Salvatore, Guadagnino, Giuliana, Angioni, Goffredo, Bargiacchi, Olivia, Ricci, Elena Delfina, Squillace, Nicola, Bonfanti, Paolo, Corti, N, Menzaghi, B, Orofino, G, Guastavigna, M, Lagi, F, Di Biagio, A, Taramasso, L, De Socio, G, Molteni, C, Madeddu, G, Salomoni, E, Pellicanò, G, Pontali, E, Bellagamba, R, Celesia, B, Cascio, A, Sarchi, E, Gulminetti, R, Calza, L, Maggi, P, Cenderello, G, Bandera, A, Carleo, M, Falasca, K, Ferrara, S, Martini, S, Guadagnino, G, Angioni, G, Bargiacchi, O, Ricci, E, Squillace, N, Bonfanti, P, Corti, Nicolò, Menzaghi, Barbara, Orofino, Giancarlo, Guastavigna, Marta, Lagi, Filippo, Di Biagio, Antonio, Taramasso, Lucia, De Socio, Giuseppe Vittorio, Molteni, Chiara, Madeddu, Giordano, Salomoni, Elena, Pellicanò, Giovanni Francesco, Pontali, Emanuele, Bellagamba, Rita, Celesia, Benedetto Maurizio, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Calza, Leonardo, Maggi, Paolo, Cenderello, Giovanni, Bandera, Alessandra, Carleo, Maria Aurora, Falasca, Katia, Ferrara, Sergio, Martini, Salvatore, Guadagnino, Giuliana, Angioni, Goffredo, Bargiacchi, Olivia, Ricci, Elena Delfina, Squillace, Nicola, and Bonfanti, Paolo

Abstract

Cardiovascular disease (CVD) is common in people with HIV (PWH), and has great impact in terms of morbidity and mortality. Several intertwined mechanisms are believed to play a role in determining the increased risk of CVD, including the effect of certain antiretrovirals; among these, the role of integrase strand-transfer inhibitors (INSTIs) is yet to be fully elucidated. We conducted a multicenter, observational study comprising 4984 PWH evaluating the antiretroviral therapy (ART)-related nature of CVD in real life settings, both in naïve vs. treatment-experienced people. A comparison was conducted between INSTIs vs. either protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs) considering demographic, baseline clinical characteristics, incidence of CVD in both 2-year and complete follow-up periods. Among 2357 PWH exposed to INSTIs, 24 people experienced CVD; the corresponding figure was 12 cases out of 2599 PWH exposed to other ART classes. At univariate and multivariate analysis, a tendency towards an increased risk of CVD was observed in the 2-year follow-up period in PWH exposed to INSTIs in the absence, however, of statistical significance. These findings leave open the hypothesis that INSTIs may play a role, albeit minimal, in determining an increased risk of CVD in PWH.

Published
2024

7. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., and Marcellini V.

Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3 weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific T cell response peaks after the first dose and is characterized by high frequencies of CD8s. T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Published
2023

8. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, Stefania, Fusco, Francesco M, Milleri, Stefano, Borrè, Silvio, Carbonara, Sergio, Lo Caputo, Sergio, Leone, Sebastiano, Gori, Giovanni, Maggi, Paolo, Cascio, Antonio, Lichtner, Miriam, Cauda, Roberto, Dal Zoppo, Sarah, Cossu, Maria V, Gori, Andrea, Roda, Silvia, Confalonieri, Paola, Bonora, Stefano, Missale, Gabriele, Codeluppi, Mauro, Mezzaroma, Ivano, Capici, Serena, Pontali, Emanuele, Libanore, Marco, Diani, Augusta, Lanini, Simone, Battella, Simone, Contino, Alessandra M, Piano Mortari, Eva, Genova, Francesco, Parente, Gessica, Dragonetti, Rosella, Colloca, Stefano, Visani, Luigi, Iannacone, Claudio, Carsetti, Rita, Folgori, Antonella, Camerini, Roberto, Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, and Marcellini, V

Subjects
immunological memory, phase 2 clinical trial, safety, Sars-CoV-2 vaccine, COVID-19, CD8, T cell response, simian adenoviral vector, General Biochemistry, Genetics and Molecular Biology, CD4, neutralizing antibodie
Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific Tcell response peaks after the first dose and is characterized by high frequencies of CD8s. Tcells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Published
2023

9. Lipids and Transaminase in Antiretroviral-Treatment-Experienced People Living with HIV, Switching to a Doravirine-Based vs. a Rilpivirine-Based Regimen: Data from a Real-Life Setting

Author

Maggi, P, Ricci, E, Martinelli, C, De Socio, G, Squillace, N, Molteni, C, Masiello, A, Orofino, G, Menzaghi, B, Bellagamba, R, Vichi, F, Celesia, B, Madeddu, G, Pellicanò, G, Carleo, M, Cascio, A, Parisini, A, Taramasso, L, Valsecchi, L, Calza, L, Rusconi, S, Sarchi, E, Martini, S, Bargiacchi, O, Falasca, K, Cenderello, G, Ferrara, S, Di Biagio, A, Bonfanti, P, Maggi, Paolo, Ricci, Elena Delfina, Martinelli, Canio Vito, De Socio, Giuseppe Vittorio, Squillace, Nicola, Molteni, Chiara, Masiello, Addolorata, Orofino, Giancarlo, Menzaghi, Barbara, Bellagamba, Rita, Vichi, Francesca, Celesia, Benedetto Maurizio, Madeddu, Giordano, Pellicanò, Giovanni Francesco, Carleo, Maria Aurora, Cascio, Antonio, Parisini, Andrea, Taramasso, Lucia, Valsecchi, Laura, Calza, Leonardo, Rusconi, Stefano, Sarchi, Eleonora, Martini, Salvatore, Bargiacchi, Olivia, Falasca, Katia, Cenderello, Giovanni, Ferrara, Sergio, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, P, Ricci, E, Martinelli, C, De Socio, G, Squillace, N, Molteni, C, Masiello, A, Orofino, G, Menzaghi, B, Bellagamba, R, Vichi, F, Celesia, B, Madeddu, G, Pellicanò, G, Carleo, M, Cascio, A, Parisini, A, Taramasso, L, Valsecchi, L, Calza, L, Rusconi, S, Sarchi, E, Martini, S, Bargiacchi, O, Falasca, K, Cenderello, G, Ferrara, S, Di Biagio, A, Bonfanti, P, Maggi, Paolo, Ricci, Elena Delfina, Martinelli, Canio Vito, De Socio, Giuseppe Vittorio, Squillace, Nicola, Molteni, Chiara, Masiello, Addolorata, Orofino, Giancarlo, Menzaghi, Barbara, Bellagamba, Rita, Vichi, Francesca, Celesia, Benedetto Maurizio, Madeddu, Giordano, Pellicanò, Giovanni Francesco, Carleo, Maria Aurora, Cascio, Antonio, Parisini, Andrea, Taramasso, Lucia, Valsecchi, Laura, Calza, Leonardo, Rusconi, Stefano, Sarchi, Eleonora, Martini, Salvatore, Bargiacchi, Olivia, Falasca, Katia, Cenderello, Giovanni, Ferrara, Sergio, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

Doravirine (DOR) is a newly approved non-nucleoside reverse transcriptase inhibitor (NNRTI). We aimed to investigate, in a real-life setting, how switching to a DOR-based regimen rather than a rilpivirine (RPV)-based regimen impacted metabolic and hepatic safety. The analysis included 551 antiretroviral treatment (ART)-experienced people living with HIV (PLWH), starting RPV-based or DOR-based regimens with viral load < 200 copies/mL, baseline (T0), and at least one control visit (6-month visit, T1). We enrolled 295 PLWH in the RPV and 256 in the DOR cohort. At T1, total cholesterol (TC), low-density lipoprotein-C (LDL-C), and triglycerides significantly decreased in both DOR and RPV cohorts, while high-density lipoprotein-C (HDL-C) only decreased in RPV-treated people. Consistently, the TC/HDL-C ratio declined more markedly in the DOR (−0.36, p < 0.0001) than in the RPV cohort (−0.08, p = 0.25) (comparison p = 0.39). Similar trends were observed when excluding the PLWH on lipid-lowering treatment from the analysis. People with normal alanine aminotransferase (ALT) levels showed a slight ALT increase in both cohorts, and those with baseline ALT > 40 IU/L experienced a significant decline (−14 IU/L, p = 0.008) only in the DOR cohort. Lipid profile improved in both cohorts, and there was a significant reduction in ALT in PLWH with higher-than-normal baseline levels on DOR-based ART.

Published
2023

10. Compassionate use of tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: an Italian experience

Author

Maffongelli, G., Cerva, C., Stingone, C., Plazzi, M. M., Fabbri, G., Vergori, A., Vitiello, P., Quirino, T., Rossotti, R., Danieli, E., Tau, P., Puoti, M., Gazzola, L., D’Arminio, A., Lanza, P., Castelli, F., Trizzino, M., Cascio, A., Costenaro, P., Manfrin, V., Ferretto, R., Colafigli, M., Latini, A., Cristaudo, C., Valentinotti, R., Luzzati, R., Salpietro, S., Carini, E., Castagna, A., Lazzarin, A., Di Biagio, A., Gianserra, L., Pennica, A., Rossetti, B., Modica, S., De Luca, A., Vittozzi, P., Pavone, P., Dettorre, G., Palmiero, G., Borgia, G., Nardini, G., Guaraldi, G., Mussini, C., Schiaroli, E., Baldelli, F., Lapadula, G., Pastore, V., Gori, A., La Monica, S., Cauda, R., Badia, L., Viale, P., Marino, R., Sozio, F., Parruti, G., Corsini, R., Magnani, G., Carleo, M. A., Pellicano', Giovanni Francesco, Nunnari, Giuseppe, Marinello, S., Cattelan, A. M., Trentalange, A., Marinaro, L., Bonora, S., Ferrara, S., Santantonio, T., Chirianni, A., Antinori, A., Sarmati, L., and Andreoni, M.

Published
2017

11. Changes of lipid profile after switching to E/C/F/TAF: data from the Italian Compassionate Use Program

Author

Vergori, A., Fabbri, G., Lorenzini, P., Plazzi, M., Maffongelli, G., Cerva, C., Vitiello, P., Quirino, T., Rossotti, R., Danieli, E., Tau, P., Puoti, M., Lanza, P., Castelli, F., Trizzino, M., Cascio, A., Costenaro, P., Manfrin, V., Ferretto, R., Colafigli, M., Latini, A., Cristaudo, C., Gianserra, L., Pennica, A., Rossetti, B., Modica, S., De Luca, A., Nardini, G., Guaraldi, G., Mussini, C., Schiaroli, E., Baldelli, F., Lapadula, G., Pastore, V., Gori, A., La Monica, S., Cauda, R., Badia, L., Viale, P., Corsini, R., Magnani, G., Carleo, M. A., Pellicano', Giovanni Francesco, Nunnari, Giuseppe, Chirianni, A., Andreoni, M., and Medicina Tropicale, A. Antinori con il patrocinio della Società Italiana di Malattie Infettive e.

Published
2017

12. HIV positive patient with HSV-2 encephalitis: case report

Author

Pagliano, P., Ascione, T., Carleo, M. A., Boccia, G., Francesco DE CARO, Tortora, F., Pagliano, Pasquale, Ascione, Tiziana, Carleo, Maria Aurora, Boccia, Giovanni, De Caro, Francesco, and Tortora, Fabio

Subjects
Adult, Male, Anti-HIV Agents, Herpesvirus 2, Human, Acyclovir, Antiretroviral Therapy, HIV Infections, Virus Replication, Antiviral Agents, Antiretroviral Therapy, Highly Active, Humans, Highly Active, Darunavir, AIDS-Related Opportunistic Infections, CD4 Lymphocyte Count, Dideoxynucleosides, Drug Substitution, Encephalitis, Herpes Simplex, HIV Protease Inhibitors, Lamivudine, Rilpivirine, Ritonavir, Herpesvirus 2, Herpes Simplex, Encephalitis, Human
Abstract

Incidence of brain infections in Human Immunodeficiency Virus (HIV) positive patients is reduced after the availability of current high active antiretroviral therapy (HAART). Herpes Simplex Virus type 2 (HSV-2) is an infrequent cause of encephalitis in HIV patients despite it is frequently involved in sexual transmitted infections. Here, we report a case of HSV-2 encephalitis occurring in a patient without full suppression of HIV replication within the brain. A 38 year-old HIV infected man was admitted to our department because of recurrent generalized seizure and fever during the previous 24 hours. Eight months before our observation the patient was switched from a protease inhibitor based regimen to a rilpivirine-based regimen without any evidence of HIV-RNA replication in the plasma. When the patient was admitted in our hospital, he was febrile and moderately confused, no deficit of cranial nerves was reported, motility was conserved, but he was unable to walk. Laboratory examinations performed at admission demonstrated an increase of cerebrospinal fluid (CSF) protein and cells with lymphocyte prevalence, and normal CSF glucose. HSV-2-DNA and HIV-RNA were present within CSF at admission. Nuclear Magnetic Resonance imaging of the brain revealed lesions of the medial part of both temporal lobes including hippocampus without any sign of bleeding. A 21-day course of acyclovir therapy was administered with consistent improvement of clinical findings and disappearance of HSV-2-DNA within CSF. After the episode, HAART was switched to a regimen with high CSF penetrability containing abacavir, lamivudine, darunavir and ritonavir. Twelve months after HSV-2 encephalitis neurologic evaluation was normal, but symptoms of depression were reported, HIV-RNA remained undetectable both in the plasma and CSF, and CD4+ lymphocytes were above 500/μL. No opportunistic infection was reported. Patients switched to regimen well tolerated such those containing rilpivirine, that have poor drug concentration within CSF could be considered at risk for opportunistic infection of the brain. Further larger investigation needs to confirm this finding.

Published
2016

15. COVID-19 among healthcare workers in a specialist infectious diseases setting in Naples, Southern Italy: results of a cross-sectional surveillance study

Author

Vincenzo Sangiovanni, Francesco Maria Fusco, M Boccardi, B Chignoli, Raffaella Pisapia, Orsola Tambaro, R Dell'Aversano, G. Di Flumeri, V. Esposito, L Atripaldi, R Bellopede, Maria Aurora Carleo, Carolina Rescigno, Nicola Maturo, Giovanni Parrella, Rosaria Viglietti, V. Iodice, Mariantonietta Pisaturo, R Punzi, Fusco, F. M., Pisaturo, M., Iodice, V., Bellopede, R., Tambaro, O., Parrella, G., Di Flumeri, G., Viglietti, R., Pisapia, R., Carleo, M. A., Boccardi, M., Atripaldi, L., Chignoli, B., Maturo, N., Rescigno, C., Esposito, V., Dell'Aversano, R., Sangiovanni, V., and Punzi, R.

Subjects
Microbiology (medical), Adult, Male, medicine.medical_specialty, Infectious Disease Transmission, Patient-to-Professional, Coronavirus disease 2019 (COVID-19), Cross-sectional study, health care facilities, manpower, and services, Health Personnel, education, Pneumonia, Viral, Infection control, Asymptomatic, Serology, Internal medicine, Pandemic, Health care, medicine, Emergency medical services, Prevalence, Cross-Sectional Studie, Surveillance, Betacoronaviru, business.industry, SARS-CoV-2, Coronavirus Infection, Emergency Medical Service, virus diseases, COVID-19, General Medicine, Middle Aged, Infectious Diseases, Italy, Population Surveillance, Healthcare worker, Female, medicine.symptom, business, Human
Abstract

A coronavirus disease 2019 (COVID-19) surveillance study was performed in March-April 2020 among asymptomatic healthcare workers (HCWs) at a specialist infectious diseases hospital in Naples, Italy. All HCWs underwent two rounds of molecular and serological testing for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). One hundred and fifteen HCWs were tested; of these, two cases of infection were identified by reverse transcriptase polymerase chain reaction and two HCWs were SARS-CoV-2 immunoglobulin G seropositive. The overall prevalence of current or probable previous infection was 3.4%. The infection rate among HCWs was reasonably low. Most of the infected HCWs had been asymptomatic for the preceding 30 days, which supports the need for periodic screening of HCWs for COVID-19.

Published
2020

16. COVID-19 among healthcare workers in a specialist infectious diseases setting in Naples, Southern Italy: results of a cross-sectional surveillance study.

Author

Fusco FM, Pisaturo M, Iodice V, Bellopede R, Tambaro O, Parrella G, Di Flumeri G, Viglietti R, Pisapia R, Carleo MA, Boccardi M, Atripaldi L, Chignoli B, Maturo N, Rescigno C, Esposito V, Dell'Aversano R, Sangiovanni V, and Punzi R

Subjects
Adult, Betacoronavirus, COVID-19, Cross-Sectional Studies, Female, Humans, Italy epidemiology, Male, Middle Aged, Pandemics, Population Surveillance, Prevalence, SARS-CoV-2, Coronavirus Infections epidemiology, Emergency Medical Services statistics & numerical data, Health Personnel statistics & numerical data, Infectious Disease Transmission, Patient-to-Professional statistics & numerical data, Pneumonia, Viral epidemiology
Abstract

A coronavirus disease 2019 (COVID-19) surveillance study was performed in March-April 2020 among asymptomatic healthcare workers (HCWs) at a specialist infectious diseases hospital in Naples, Italy. All HCWs underwent two rounds of molecular and serological testing for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). One hundred and fifteen HCWs were tested; of these, two cases of infection were identified by reverse transcriptase polymerase chain reaction and two HCWs were SARS-CoV-2 immunoglobulin G seropositive. The overall prevalence of current or probable previous infection was 3.4%. The infection rate among HCWs was reasonably low. Most of the infected HCWs had been asymptomatic for the preceding 30 days, which supports the need for periodic screening of HCWs for COVID-19., (Copyright © 2020 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.)

Published
2020
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