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3. List of contributors

Author

Ahlborn, H., primary, Aibibu, D., additional, Akkerman, R., additional, Aurich, M., additional, Bien, S., additional, Bilisik, K., additional, Bogdanovich, A.E., additional, Böhler, P., additional, Bulat, M., additional, Carosella, S., additional, Cherif, C., additional, Duchamp, B., additional, Ebel, C., additional, Glessner, P., additional, Gnädinger, F., additional, Gries, T., additional, Heieck, F., additional, Heinze, T., additional, Hild, M., additional, Kern, C., additional, Kind, K., additional, Kyosev, Y., additional, Legrand, X., additional, Lengersdorf, M., additional, Mammitzsch, J., additional, Matthaei, M., additional, Michael, M., additional, Michaelis, D., additional, Middendorf, P., additional, Mierzwa, A., additional, Milwich, M., additional, Müller, B., additional, Pickett, A., additional, Regel, F., additional, Schäfer, J., additional, Schmidt, M., additional, Schmieder, A., additional, Schreiber, F., additional, Soulat, D., additional, van Ravenhorst, J.H., additional, West, S., additional, and Zuleger, S., additional

Published
2016
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4. Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial

Author

Fabbiani, M, Gagliardini, R, Ciccarelli, N, Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Del Pin, B, Lombardi, F, D'Avino, A, Foca, E, Colafigli, M, Cauda, R, Di Giambenedetto, S, De Luca, A, Mondi, A, Borghetti, A, Baldonero, E, Belmonti, S, Lamonica, S, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Di Pietro, M, Blanc, P, Degli Esposti, A, Mariabelli, E, Marini, S, Poggi, A, Quiros Roldan, E, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Fabbiani M., Gagliardini R., Ciccarelli N., Roldan E. Q., Latini A., d'Ettorre G., Antinori A., Castagna A., Orofino G., Francisci D., Chinello P., Madeddu G., Grima P., Rusconi S., Del Pin B., Lombardi F., D'Avino A., Foca E., Colafigli M., Cauda R., Di Giambenedetto S., De Luca A., Mondi A., Borghetti A., Baldonero E., Belmonti S., Lamonica S., Sidella L., Tamburrini E., Visconti E., Giacometti A., Barchiesi F., Castelli P., Cirioni O., Mazzocato S., Di Pietro M., Blanc P., Degli Esposti A., Mariabelli E., Marini S., Poggi A., Quiros Roldan E., Amadasi S., Apostoli A., Biasi L., Bonito A., Brianese N., Compostella S., Ferraresi A., Motta D., Mughini M. T., Celesia B. M., Gussio M., Sofia S., Tana M., Tundo P., Viscoli C., De Hoffer L., Di Biagio A., Grignolo S., Parisini A., Schenone E., Taramasso L., Manconi P. E., Boccone A., Ortu F., Piano P., Serusi L., Puoti M., Moioli M. C., Rossotti R., Travi G., Ventura F., Galli M., Di Nardo Stuppino S., Di Cristo V., Giacomelli A., Vimercati V., Viale P., Gori A., Rizzardini G., Capetti A., Carenzi L., Mazza F., Meraviglia P., Rosa S., Zucchi P., Mineo M., Giuliani M., Pacifici A., Pimpinelli F., Solivetti F., Stivali F., Angelici F., Bellagamba R., Delle Rose D., Fezza R., Libertone R., Mosti S., Narciso P., Nicastri E., Ottou S., Tomassi C., Vlassi C., Zaccarelli M., Zoppe F., Vullo V., Altavilla F., Ceccarelli G., Fantauzzi A., Gebremeskel S., Lo Menzo S., Mezzaroma I., Tierno F., Petrosillo N., Boumis E., Cicalini S., Grilli E., Musso M., Stella C., Mura M. S., Bagella P., Mannazzu M., Soddu V., Caramello P., Carcieri C., Carosella S., Farenga M., Scotton P. G., Rossi M. C., Concia E., Corsini F., Gricolo C., Lanzafame M., Lattuada E., Leonardi S., Rigo F., Lazzarin A., Bigoloni A., Carini E., Nozza S., Spagnuolo V., Belfiori B., Malincarne L., Schiaroli E., Sfara C., Tosti A., Sacchini D., Ruggieri A., Valdatta C., Fabbiani, M, Gagliardini, R, Ciccarelli, N, Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Del Pin, B, Lombardi, F, D'Avino, A, Foca, E, Colafigli, M, Cauda, R, Di Giambenedetto, S, De Luca, A, Mondi, A, Borghetti, A, Baldonero, E, Belmonti, S, Lamonica, S, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Di Pietro, M, Blanc, P, Degli Esposti, A, Mariabelli, E, Marini, S, Poggi, A, Quiros Roldan, E, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Fabbiani M., Gagliardini R., Ciccarelli N., Roldan E. Q., Latini A., d'Ettorre G., Antinori A., Castagna A., Orofino G., Francisci D., Chinello P., Madeddu G., Grima P., Rusconi S., Del Pin B., Lombardi F., D'Avino A., Foca E., Colafigli M., Cauda R., Di Giambenedetto S., De Luca A., Mondi A., Borghetti A., Baldonero E., Belmonti S., Lamonica S., Sidella L., Tamburrini E., Visconti E., Giacometti A., Barchiesi F., Castelli P., Cirioni O., Mazzocato S., Di Pietro M., Blanc P., Degli Esposti A., Mariabelli E., Marini S., Poggi A., Quiros Roldan E., Amadasi S., Apostoli A., Biasi L., Bonito A., Brianese N., Compostella S., Ferraresi A., Motta D., Mughini M. T., Celesia B. M., Gussio M., Sofia S., Tana M., Tundo P., Viscoli C., De Hoffer L., Di Biagio A., Grignolo S., Parisini A., Schenone E., Taramasso L., Manconi P. E., Boccone A., Ortu F., Piano P., Serusi L., Puoti M., Moioli M. C., Rossotti R., Travi G., Ventura F., Galli M., Di Nardo Stuppino S., Di Cristo V., Giacomelli A., Vimercati V., Viale P., Gori A., Rizzardini G., Capetti A., Carenzi L., Mazza F., Meraviglia P., Rosa S., Zucchi P., Mineo M., Giuliani M., Pacifici A., Pimpinelli F., Solivetti F., Stivali F., Angelici F., Bellagamba R., Delle Rose D., Fezza R., Libertone R., Mosti S., Narciso P., Nicastri E., Ottou S., Tomassi C., Vlassi C., Zaccarelli M., Zoppe F., Vullo V., Altavilla F., Ceccarelli G., Fantauzzi A., Gebremeskel S., Lo Menzo S., Mezzaroma I., Tierno F., Petrosillo N., Boumis E., Cicalini S., Grilli E., Musso M., Stella C., Mura M. S., Bagella P., Mannazzu M., Soddu V., Caramello P., Carcieri C., Carosella S., Farenga M., Scotton P. G., Rossi M. C., Concia E., Corsini F., Gricolo C., Lanzafame M., Lattuada E., Leonardi S., Rigo F., Lazzarin A., Bigoloni A., Carini E., Nozza S., Spagnuolo V., Belfiori B., Malincarne L., Schiaroli E., Sfara C., Tosti A., Sacchini D., Ruggieri A., and Valdatta C.

Abstract

Objectives: To investigate the long-term safety and efficacy of a treatment switch to dual ART with atazanavir/ritonavir+lamivudine versus continuing a standard regimen with atazanavir/ritonavir+2NRTI in virologically suppressed patients. Methods: ATLAS-M is a 96 week open-label, randomized, non-inferiority (margin -12%) trial enrolling HIV-infected adults on atazanavir/ritonavir+2NRTI, with stable HIV-RNA < 50 copies/mL and CD4 counts.200 cells/mm3. At baseline, patients were randomized 1:1 to switch to atazanavir/ritonavir+lamivudine or to continue the previous regimen. Here, we report the 96 week efficacy and safety data. The study was registered with ClinicalTrials.gov, number NCT01599364. Results: Overall, 266 subjects were enrolled (133 in each arm). At 96 weeks, in the ITT population, patients free of treatment failure totalled 103 (77.4%) with atazanavir/ritonavir+lamivudine and 87 (65.4%) with triple therapy (difference +12.0%, 95% CI +1.2/+22.8, P=0.030), demonstrating the superiority of dual therapy. Two (1.5%) and 9 (6.8%) virological failures occurred in the dual-therapy arm and the triple-therapy arm, respectively, without development of resistance to any study drug. Clinical adverse events occurred at similar rates in both arms. A higher frequency of grade 3-4 hyperbilirubinemia (66.9% versus 50.4%, P=0.006) and hypertriglyceridaemia (6.8% versus 1.5%, P=0.031) occurred with dual therapy, although this never led to treatment discontinuation. A significant improvement in renal function and lumbar spine bone mineral density occurred in the dual-therapy arm. The evolution of CD4, HIV-DNA levels and neurocognitive performance was similar in both arms. Conclusions: In this randomized study, a treatment switch to atazanavir/ritonavir+lamivudine was superior over the continuation of atazanavir/ritonavir+2NRTI in virologically suppressed patients, with a sustained benefit in terms of improved renal function and bone mineral density.

Published
2018

5. Treatment simplification to atazanavir/ritonavir+lamivudine versus maintenance of atazanavir/ritonavir+two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Author

Di Giambenedetto, S, Fabbiani, M, Quiros Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Di Pietro, M, Mondi, A, Ciccarelli, N, Borghetti, A, Foca, E, Colafigli, M, De Luca, A, Cauda, R, Baldonero, E, Belmonti, S, D'Avino, A, Gagliardini, R, Lamonica, S, Lombardi, F, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Blanc, P, Degli Esposti, A, Del Pin, B, Mariabelli, E, Marini, S, Poggi, A, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Di Giambenedetto S., Fabbiani M., Quiros Roldan E., Latini A., D'Ettorre G., Antinori A., Castagna A., Orofino G., Francisci D., Chinello P., Madeddu G., Grima P., Rusconi S., Di Pietro M., Mondi A., Ciccarelli N., Borghetti A., Foca E., Colafigli M., De Luca A., Cauda R., Baldonero E., Belmonti S., D'Avino A., Gagliardini R., Lamonica S., Lombardi F., Sidella L., Tamburrini E., Visconti E., Giacometti A., Barchiesi F., Castelli P., Cirioni O., Mazzocato S., Blanc P., Degli Esposti A., Del Pin B., Mariabelli E., Marini S., Poggi A., Amadasi S., Apostoli A., Biasi L., Bonito A., Brianese N., Compostella S., Ferraresi A., Motta D., Mughini M. T., Celesia B. M., Gussio M., Sofia S., Tana M., Tundo P., Viscoli C., De Hoffer L., Di Biagio A., Grignolo S., Parisini A., Schenone E., Taramasso L., Manconi P. E., Boccone A., Ortu F., Piano P., Serusi L., Puoti M., Moioli M. C., Rossotti R., Travi G., Ventura F., Galli M., Di Nardo Stuppino S., Di Cristo V., Giacomelli A., Vimercati V., Viale P., Gori A., Rizzardini G., Capetti A., Carenzi L., Mazza F., Meraviglia P., Rosa S., Zucchi P., Mineo M., Giuliani M., Pacifici A., Pimpinelli F., Solivetti F., Stivali F., Angelici F., Bellagamba R., Delle Rose D., Fezza R., Libertone R., Mosti S., Narciso P., Nicastri E., Ottou S., Tomassi C., Vlassi C., Zaccarelli M., Zoppe F., Vullo V., Altavilla F., Ceccarelli G., Fantauzzi A., Gebremeskel S., Lo Menzo S., Mezzaroma I., Tierno F., Petrosillo N., Boumis E., Cicalini S., Grilli E., Musso M., Stella C., Mura M. S., Bagella P., Mannazzu M., Soddu V., Caramello P., Carcieri C., Carosella S., Farenga M., Scotton P. G., Rossi M. C., Concia E., Corsini F., Gricolo C., Lanzafame M., Lattuada E., Leonardi S., Rigo F., Lazzarin A., Bigoloni A., Carini E., Nozza S., Spagnuolo V., Belfiori B., Malincarne L., Schiaroli E., Sfara C., Tosti A., Sacchini D., Ruggieri A., Valdatta C., Di Giambenedetto, S, Fabbiani, M, Quiros Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Di Pietro, M, Mondi, A, Ciccarelli, N, Borghetti, A, Foca, E, Colafigli, M, De Luca, A, Cauda, R, Baldonero, E, Belmonti, S, D'Avino, A, Gagliardini, R, Lamonica, S, Lombardi, F, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Blanc, P, Degli Esposti, A, Del Pin, B, Mariabelli, E, Marini, S, Poggi, A, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Di Giambenedetto S., Fabbiani M., Quiros Roldan E., Latini A., D'Ettorre G., Antinori A., Castagna A., Orofino G., Francisci D., Chinello P., Madeddu G., Grima P., Rusconi S., Di Pietro M., Mondi A., Ciccarelli N., Borghetti A., Foca E., Colafigli M., De Luca A., Cauda R., Baldonero E., Belmonti S., D'Avino A., Gagliardini R., Lamonica S., Lombardi F., Sidella L., Tamburrini E., Visconti E., Giacometti A., Barchiesi F., Castelli P., Cirioni O., Mazzocato S., Blanc P., Degli Esposti A., Del Pin B., Mariabelli E., Marini S., Poggi A., Amadasi S., Apostoli A., Biasi L., Bonito A., Brianese N., Compostella S., Ferraresi A., Motta D., Mughini M. T., Celesia B. M., Gussio M., Sofia S., Tana M., Tundo P., Viscoli C., De Hoffer L., Di Biagio A., Grignolo S., Parisini A., Schenone E., Taramasso L., Manconi P. E., Boccone A., Ortu F., Piano P., Serusi L., Puoti M., Moioli M. C., Rossotti R., Travi G., Ventura F., Galli M., Di Nardo Stuppino S., Di Cristo V., Giacomelli A., Vimercati V., Viale P., Gori A., Rizzardini G., Capetti A., Carenzi L., Mazza F., Meraviglia P., Rosa S., Zucchi P., Mineo M., Giuliani M., Pacifici A., Pimpinelli F., Solivetti F., Stivali F., Angelici F., Bellagamba R., Delle Rose D., Fezza R., Libertone R., Mosti S., Narciso P., Nicastri E., Ottou S., Tomassi C., Vlassi C., Zaccarelli M., Zoppe F., Vullo V., Altavilla F., Ceccarelli G., Fantauzzi A., Gebremeskel S., Lo Menzo S., Mezzaroma I., Tierno F., Petrosillo N., Boumis E., Cicalini S., Grilli E., Musso M., Stella C., Mura M. S., Bagella P., Mannazzu M., Soddu V., Caramello P., Carcieri C., Carosella S., Farenga M., Scotton P. G., Rossi M. C., Concia E., Corsini F., Gricolo C., Lanzafame M., Lattuada E., Leonardi S., Rigo F., Lazzarin A., Bigoloni A., Carini E., Nozza S., Spagnuolo V., Belfiori B., Malincarne L., Schiaroli E., Sfara C., Tosti A., Sacchini D., Ruggieri A., and Valdatta C.

Abstract

Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir+two NRTIs, with stable HIV-RNA <50 copies/mL and CD4+>200 cells/mm3. Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300mg of atazanavir/ 100mg of ritonavir once daily and 300mg of lamivudine once daily (atazanavir/ritonavir+lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir+two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA <50 copies/mL at week 48 of the ITT-exposed (ITT-e) analysis with switch"failure. The non-inferiority margin was 12%. This study is registered at ClinicalTrials.gov, number NCT01599364. Results: Between July 2011 and June 2014, 266 patients were randomized (133 to each arm). After 48 weeks, the primary study outcome was met by 119 of 133 patients (89.5%) in the atazanavir/ritonavir+lamivudine arm and 106 of 133 patients (79.7%) in the atazanavir/ritonavir+two NRTIs arm [difference atazanavir/ritonavir+ lamivudine versus atazanavir/ritonavir+two NRTIs arm: +9.8% (95% CI+1.2 to+18.4)], demonstrating non-inferiority and superior efficacy of the atazanavir/ritonavir+lamivudine arm. Virological failure occurred in two (1.5%) patients in the atazanavir/ritonavir+lamivudine arm and six (4.5%) patients in the atazanavir/ritonavir+ two NRTIs arm, without resistance selection. A similar proportion of adverse events occurred in both arms. Conclusions: Treatment simplification to atazanavir/rito

Published
2017

6. Switch to dolutegravir and unboosted atazanavir in HIV-1 infected patients with undetectable viral load and long exposure to antiretroviral therapy

Author

Castagna, A., Rusconi, S., Gulminetti, R., Bonora, S., Mazzola, G., Quiros-Roldan, M. E., De Socio, G. V., Ladisa, N., Carosella, S., Cattelan, A., Di Giambenedetto, Simona, Mena, M., Poli, A., Galli, L., Riva, A., Di Giambenedetto S. (ORCID:0000-0001-6990-5076), Castagna, A., Rusconi, S., Gulminetti, R., Bonora, S., Mazzola, G., Quiros-Roldan, M. E., De Socio, G. V., Ladisa, N., Carosella, S., Cattelan, A., Di Giambenedetto, Simona, Mena, M., Poli, A., Galli, L., Riva, A., and Di Giambenedetto S. (ORCID:0000-0001-6990-5076)

Abstract

We evaluated the efficacy and safety of a two-drug regimen including dolutegravir (DTG) and unboosted atazanavir (uATV) in 151 HIV-1 infected patients with HIV-RNA of more than 50 copies/ml. During a median follow-up of 62 (42-97) weeks, two virological failures (1%) and 13 treatment discontinuations (9%) occurred; the 48-week probability of virological failure was 0.8% (95% confidence interval 0.2-5.6%). Switch to DTG + uATV may represent a boosting and transcriptase reverse inhibitors sparing otion in individuals with long exposure to antiretroviral therapy and risk of cardiovascular disease.

Published
2019

7. Treatment simplification to atazanavir/ritonavir+lamivudine versus maintenance of atazanavir/ritonavir+two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Author

Di Giambenedetto, S., Fabbiani, M., Quiros Roldan, E., Latini, A., D'Ettorre, G., Antinori, A., Castagna, A., Orofino, G., Francisci, D., Chinello, P., Madeddu, G., Grima, P., Rusconi, S., Di Pietro, M., Mondi, A., Ciccarelli, N., Borghetti, A., Focà, E., Colafigli, M., De Luca, A., Cauda, R., Baldonero, E., Belmonti, S., D'Avino, A., Gagliardini, R., Lamonica, S., Lombardi, F., Sidella, L., Tamburrini, E., Visconti, E., Giacometti, A., Barchiesi, F., Castelli, P., Cirioni, O., Mazzocato, S., Blanc, P., Degli Esposti, A., Del Pin, B., Mariabelli, E., Marini, S., Poggi, A., Amadasi, S., Apostoli, A., Biasi, L., Bonito, A., Brianese, N., Compostella, S., Ferraresi, A., Motta, D., Mughini, M. T., Celesia, B. M., Gussio, M., Sofia, S., Tana, M., Tundo, P., Viscoli, C., De Hoffer, L., Di Biagio, A., Grignolo, S., Parisini, A., Schenone, E., Taramasso, L., Manconi, P. E., Boccone, A., Ortu, F., Piano, P., Serusi, L., Puoti, M., Moioli, M. C., Rossotti, R., Travi, G., Ventura, F., Galli, M., Di Nardo Stuppino, S., Di Cristo, V., Giacomelli, A., Vimercati, V., Viale, P., Gori, A., Rizzardini, G., Capetti, A., Carenzi, L., Mazza, F., Meraviglia, P., Rosa, S., Zucchi, P., Mineo, M., Giuliani, M., Pacifici, A., Pimpinelli, F., Solivetti, F., Stivali, F., Angelici, F., Bellagamba, R., Delle Rose, D., Fezza, R., Libertone, R., Mosti, S., Narciso, P., Nicastri, E., Ottou, S., Tomassi, C., Vlassi, C., Zaccarelli, M., Zoppè, F., Vullo, V., Altavilla, F., Ceccarelli, G., Fantauzzi, A., Gebremeskel, S., Lo Menzo, S., Mezzaroma, I., Tierno, F., Petrosillo, N., Boumis, E., Cicalini, S., Grilli, E., Musso, M., Stella, C., Mura, M. S., Bagella, P., Mannazzu, M., Soddu, V., Caramello, P., Carcieri, C., Carosella, S., Farenga, M., Scotton, P. G., Rossi, M. C., Concia, E., Corsini, F., Gricolo, C., Lanzafame, M., Lattuada, E., Leonardi, S., Rigo, F., Lazzarin, A., Bigoloni, A., Carini, E., Nozza, S., Spagnuolo, V., Belfiori, B., Malincarne, L., Schiaroli, E., Sfara, C., Tosti, A., Sacchini, D., Ruggieri, A., Valdatta, C., Di Giambenedetto, S, Fabbiani, M, Quiros Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Di Pietro, M, Mondi, A, Ciccarelli, N, Borghetti, A, Foca, E, Colafigli, M, De Luca, A, Cauda, R, Baldonero, E, Belmonti, S, D'Avino, A, Gagliardini, R, Lamonica, S, Lombardi, F, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Blanc, P, Degli Esposti, A, Del Pin, B, Mariabelli, E, Marini, S, Poggi, A, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Roldan, Eq, Focà, E, and on behalf of the Atlas-M Study, Group

Subjects
Male, 0301 basic medicine, HIV Infections, ART HIV, Gastroenterology, law.invention, 0302 clinical medicine, Randomized controlled trial, immune system diseases, law, Antiretroviral Therapy, Highly Active, HIV Infection, Pharmacology (medical), Viral, 030212 general & internal medicine, Adult, Atazanavir Sulfate, Coinfection, Drug Therapy, Combination, Female, HIV-1, Humans, Lamivudine, Middle Aged, RNA, Viral, Ritonavir, Viral Load, Young Adult, Pharmacology, Infectious Diseases, virus diseases, dual therapy, Combination, Viral load, Human, medicine.drug, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, Highly Active, Adverse effect, business.industry, Surgery, Atazanavir, Regimen, RNA, business
Abstract

Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir+two NRTIs, with stable HIV-RNA 200 cells/mm3. Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300mg of atazanavir/ 100mg of ritonavir once daily and 300mg of lamivudine once daily (atazanavir/ritonavir+lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir+two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA

Published
2017

8. Investigation of a new out of autoclave placement process, mould concepts/release strategies and reusable heated bagging material

Author

Heudorfer Klaus, Engelfried M., Fial J., Carosella S., and Middendorf P.

Subjects
tape placement, out of autoclave prepreg, release strategy, reusable bagging material
Abstract

Carbon fibre reinforced plastic (CFRP) parts provide advantages for light weight structures in aeronautical applications. However, state of the art manufacturing methods are too slow to meet the quantities needed for future aircraft demands. This paper focuses on a manufacturing process to improve overall cycle time from cutting the prepreg material to finishing the cured part. The process is based on a new tape laying process, which is capable to process 300 mm wide, unidirectional prepreg tapes, directly into the final three-dimensional part geometry. This is possible due to active in plane shearing of the tapes, which compensates length differences while placing it onto double curved surfaces. A heated mould ensures the needed tack to properly attach the prepreg tapes on the mould or other prepreg material. This mould is equipped with a new heating concept allowing heating rates of above 10 K/min. To avoid transfer issues with the shaped prepreg material the mould is also used for curing. The process is designed to use out of autoclave prepreg material, allowing to cure with a consolidation pressure of only about 1 bar. Combinations of permanent (mould surface) and semi-permanent (release agents) release strategies are investigated. Release agent application methods and the amount of possible demoulding steps without recoating are tested to determine the most suited solution for a minimum mould preparation time. Finally, reusable bagging material with integrated heating elements is investigated. This research is part of the EFFICOMP project, funded by Horizon 2020.

Published
2017

12. COMBINED EFFECTS OF 900 MHZ RADIOFREQUENCY RADIATION AND VINCLOZOLIN ON NIH 3T3 CELL CULTURES

Author

Capri M, Scarcella E, Bianchi E, Lanzarini C, Carosella S, Mersica P, Agostani C, Bersani F, Zeni O, d?Ambrosio G, Massa R, Scarfì MR, Juutilainen J, Franceschi C, D'Ambrosio, Guglielmo, Massa, Rita, M., Capri, E., Scarcella, E., Bianchi, C., Lanzarini, S., Carosella, P., Mersica, C., Agostani, F., Bersani, O., Zeni, M. R., Scarfì, J., Juutilainen, C., Franceschi, Ccapri, M, Scarcella, E, Bianchi, E, Lanzarini, C, Carosella, S, Mersica, P, Agostani, C, Bersani, F, Zeni, O, D, Ambrosio, G, Scarf, Mr, and Juutilainen, J. AND FRANCESCHI C.

Published
2003

17. Determinants of virologic and immunologic outcomes in chronically HIV-infected subjects undergoing repeated treatment interruptions: The Istituto Superiore di Sanità-Pulsed Antiretroviral Therapy (ISS-PART) study

Author

Palmisano, L., Giuliano, M., Bucciardini, R., Fragola, V., Andreotti, M., Galluzzo, C. M., Pirillo, M. F., Weimer, L. E., Arcieri, R., Germinario, E. A. P., Amici, R., Mancini, M. G., D'Arminio Monforte, A., Castelli, F., Caramello, P., Vella, S., Abrescia, N., Figoni, M., Viglietti, R., Angarano, G., Saracino, A., Anselmo, M., Antinori, A., Sette, P., Zaccarelli, M., Liuzzi, G., Arlotti, M., Martelli, L. T., Ortolani, P., Bassetti, D., Di Biagio, A., Bisio, F., Bellissima, P., Branz, F., Dorigoni, N., Cadeo, G., Vangi, D., Bertelli, D., Bergamasco, A., Caggese, L., Volonterio, A., Orofino, G. C., Carosella, S., Gennero, L., Caremani, M., Tacconi, D., Carosi, G., Tomasoni, L., Patroni, A., Chiodo, F., Borderi, M., Calza, L., Gritti, F., Fasulo, G., Chirianni, A., Gargiulo, M., Colomba, A., Dalle Nogare, E. R., Di Lorenzo, F., Prestileo, T., Bini, T., Cicconi, P., De Lalla, F., Giordani, M. T., De Stefano, C., De Stefano, G., Delia, S., Ciardi, M., Di Perri, G., Sinicco, A., Sales, P., Dini, M., Simeone, M., Esposito, R., Guaraldi, G., Beghetto, B., Fatuzzo, F., La Rosa, R., Ferrari, C., Calzetti, C., Ferraro, T., Cosco, L., Ghinelli, F., Sighinolfi, L., Guadagnino, V., Caroleo, B., Izzi, A., Izzo, C., Franco, A., Lazzarin, A., Castagna, A., Fusetti, G., Leoncini, F., Pozzi, M., Sbaragli, S., Marzetti, M., Magnani, G., Bonazzi, L., Barchi, E., Zoboli, G., Pintus, A., Mandas, A., Soddu, M. L., Zucca, F., Mannucci, P. M., Gringeri, A., Marani Toro, G., Graziani, R. V., Consorti, A., Mazzotta, F., Di Pietro, M., Ble, C., Meneghetti, F., Sasset, L., Cattelan, A. M., Menichetti, F., Savalli, E., Mian, P., Pristera, R., Mignani, E., Artioli, S., Mura, M. S., Mannazzu, M., Narciso, P., Bellagamba, R., Orani, A., Perini, P., Ortona, L., De Luca, A., Murri, R., Pagano, G., Alessandrini, A., Paladini, A., Vinattieri, M. A., Carbonai, S., Pastore, G., Ladina, N., Tateo, M., Piersantelli, N., Penco, G., Petrelli, E., Balducci, M., Pippi, L., Gonnelli, A., Puppo, F., Murdaca, G., Raise, E., Pasquirucci, A., Riccio, G., Bartolacci, V., Carrega, G., Rizzardini, G., Migliorino, G., Russo, R., Casentino, S., Celesia, M., Soranzo, M. L., Macor, A., Salassa, B., Soscia, F., Roberti, L., Di Toro, M. T., Stagno, A., Beltrami, C., Suter, F., Maggiolo, F., Ripamonti, D., Tantimonaco, G., Grisorio, B., Tassara, A., Rossi, P., Tinelli, M., Regazzetti, A., Tirelli, U., Voltaggio, G., Cinelli, R., Toti, M., Baldari, M., Carli, T., Ricciardi, B., Trezzi, M., Vigevani, G. M., Capetti, A., Landonio, S., Vullo, V., Massetti, P., Zauli, T., and Casolari, S.

Subjects
Adult, Male, medicine.medical_specialty, Anti-HIV Agents, medicine.medical_treatment, HIV Infections, Drug resistance, Drug Administration Schedule, law.invention, Randomized controlled trial, Drug Resistance, Multiple, Viral, law, Internal medicine, medicine, Humans, Pharmacology (medical), Protease inhibitor (pharmacology), Structured treatment interruptions, Chemotherapy, Reverse-transcriptase inhibitor, biology, business.industry, HIV, Middle Aged, biology.organism_classification, CD4 Lymphocyte Count, Clinical trial, Chronic infection, Regimen, Infectious Diseases, Immunology, Lentivirus, RNA, Viral, Female, business, medicine.drug
Abstract

Background: Factors influencing the outcome of structured treatment interruptions (STIs) in HIV chronic infection are not fully elucidated. Methods: In ISS-PART, 273 subjects were randomly assigned to arm A (137 assigned to continuous highly active antiretroviral therapy [HAART]) and arm B (136 assigned to 5 STIs of 1, 1, 2, 2, and 3 months'duration, each followed by 3 months of therapy). Main outcome measures were the proportion of subjects with a CD4 count >500 cells/mm 3 , the rate of virologic failure, and the emergence of resistance at 24 months. Results: The proportion of subjects with a CD4 count >500 cells/mm 3 was higher in arm A than in arm B (86.5% vs. 69.1%; P = 0.0075). Pre-HAART CD4 cell count and male gender were independent predictors of a CD4 count >500 cells/mm 3 in arm B. The overall risk of virologic failure was not increased in arm B; however, it was higher in the 38 subjects who had resistance mutations in the rebounding virus. Archived mutations at baseline and the use of a regimen that included an unboosted protease inhibitor (PI), compared with nonnucleoside reverse transcriptase inhibitor-based HAART, independently predicted the emergence of plasma mutations during STI (P = 0.002 for DNA mutations and P = 0.048 for PI-based HAART). Conclusions: Our results suggest that patients with preexisting mutations and treated with unboosted PI-based HAART should not be enrolled in studies of time-fixed treatment interruptions, being at higher risk of developing plasma mutations during STI and virologic failure at therapy reinstitution.

Published
2007

19. Switch to dolutegravir and unboosted atazanavir in HIV-1 infected patients with undetectable viral load and long exposure to antiretroviral therapy

Author

Andrea Poli, Agostino Riva, Simona Di Giambenedetto, Roberto Gulminetti, Antonella Castagna, Sinibaldo Carosella, Giovanni Mazzola, Stefano Bonora, Anna Maria Cattelan, Stefano Rusconi, Laura Galli, Maria Eugenia Quiros-Roldan, Giuseppe Vittorio De Socio, Maurizio Mena, Nicoletta Ladisa, Castagna, A., Rusconi, S., Gulminetti, R., Bonora, S., Mazzola, G., Quiros-Roldan, M. E., De Socio, G. V., Ladisa, N., Carosella, S., Cattelan, A., Di Giambenedetto, S., Mena, M., Poli, A., Galli, L., and Riva, A.

Subjects
0301 basic medicine, Male, HIV Infections, Kaplan-Meier Estimate, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Immunology and Allergy, Medicine, Pharmacology (medical), 030212 general & internal medicine, Drug Substitution, Health Policy, virus diseases, Middle Aged, Viral Load, dolutegravir, Treatment Outcome, Infectious Diseases, Dolutegravir, RNA, Viral, Drug Therapy, Combination, Female, Viral load, Heterocyclic Compounds, 3-Ring, medicine.drug, medicine.medical_specialty, Pyridones, Immunology, Atazanavir Sulfate, antiretroviral therapy, switch strategy, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Pharmacotherapy, Internal medicine, Oxazines, Humans, HIV Integrase Inhibitors, dual therapy, business.industry, Antiretroviral therapy, Discontinuation, Atazanavir, CD4 Lymphocyte Count, Regimen, 030104 developmental biology, chemistry, HIV-1, business
Abstract

We evaluated the efficacy and safety of a two-drug regimen including dolutegravir (DTG) and unboosted atazanavir (uATV) in 151 HIV-1 infected patients with HIV-RNA of more than 50 copies/ml. During a median follow-up of 62 (42-97) weeks, two virological failures (1%) and 13 treatment discontinuations (9%) occurred; the 48-week probability of virological failure was 0.8% (95% confidence interval 0.2-5.6%). Switch to DTG + uATV may represent a boosting and transcriptase reverse inhibitors sparing otion in individuals with long exposure to antiretroviral therapy and risk of cardiovascular disease.

Published
2019

20. 50 Hz sinusoidal magnetic fields do not affect human lymphocyte activation and proliferationin vitro

Author

Pietro Mesirca, Daniel Remondini, Miriam Capri, Sara Pasi, Gastone Castellani, Claudio Franceschi, Ferdinando Bersani, Simona Carosella, CAPRI M, MESIRCA P, REMONDINI D, CAROSELLA S, PASI S, CASTELLANI G, FRANCESCHI C, and BERSANI F.

Subjects
Adult, Biophysics, Biology, Lymphocyte Activation, Peripheral blood mononuclear cell, Flow cytometry, Magnetics, Structural Biology, medicine, Humans, Molecular Biology, Aged, Cell Proliferation, medicine.diagnostic_test, DNA synthesis, Cell growth, Cell Cycle, Cell Biology, Cell cycle, Flow Cytometry, In vitro, Magnetic field, Cell biology, Phenotype, Immunology, Cell activation
Abstract

In the last 30 years, an increasing public concern about the possible harmful effects of electromagnetic fields generated by power lines and domestic appliances has pushed the scientific community to search for a correct and comprehensive answer to this problem. In this work the effects of exposure to 50 Hz sinusoidal magnetic fields, with a magnetic flux density of 0.05 mT and 2.5 mT (peak values), were studied on human peripheral blood mononuclear cells (PBMCs) collected from healthy young and elderly donors. Cell activation and proliferation were investigated by using flow cytometry techniques and 3H-TdR incorporation assays, respectively. The results obtained indicated that exposure to the fields altered neither DNA synthesis nor the capacity of lymphocytes to enter the activation phase and progress into the cell cycle. Thus, the conclusions are that two important functional phases of human lymphocytes, such as activation and proliferation, are not affected by exposures to 50 Hz magnetic fields similar to those found under power lines.

Published
2004

21. Vacuum Chamber Infusion for Fiber-Reinforced Composites.

Author

Grisin B, Carosella S, and Middendorf P

Abstract

A new approach to an automatable fiber impregnation and consolidation process for the manufacturing of fiber-reinforced composite parts is presented in this article. Therefore, a vacuum chamber sealing machine classically used in food packaging is modified for this approach-Vacuum Chamber Infusion (VCI). Dry fiber placement (DFP) preforms, made from 30 k carbon fiber tape, with different layer amounts and fiber orientations, are infused with the VCI and with the state-of-the-art process-Vacuum Assisted Process (VAP)-as the reference. VCI uses a closed system that is evacuated once, while VAP uses a permanently evacuated open system. Since process management greatly influences material properties, the mechanical properties, void content, and fiber volume fraction (FVF) are analyzed. In addition, the study aims to identify how the complexity of a resin infusion process can be reduced, the automation potential can be increased, and the number of consumables can be reduced. Comparable material characteristics and a reduction in consumables, setup complexity, and manufacturing time by a factor of four could be approved for VCI. A void content of less than 2% is measured for both processes and an FVF of 39% for VCI and 45% for VAP is achieved.

Published
2024
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22. Dry Fibre Placement: The Influence of Process Parameters on Mechanical Laminate Properties and Infusion Behaviour.

Author

Grisin B, Carosella S, and Middendorf P

Abstract

Within the dry fibre placement (DFP) process, spread and pre-bindered carbon fibre rovings are automatically processed into dry textile preforms using 2-D and 3-D laying systems. The aim was to automate existing hand lay-up processes, reducing the complexity, increasing robustness, and facilitating the handling of the DFP technology. Process reliability, low waste rates, and flexible production are demonstrated. In this publication, the influences of the process parameters, 2 mm wide gaps and the percentage of 90° plies in the laminate, are investigated with regard to the mechanical properties, the permeability, and the infusion times in the preform z-direction (thickness). The effects on stiffness and strength are compared for several use cases. An approach to determine the infusion times as a function of the laminate thickness, the ply structure, and 2 mm wide gaps is demonstrated and analysed using vacuum-assisted process (VAP) infusion tests. The investigations are performed with carbon fibre tows (24 k), a reactive epoxy-based binder system, and a thermoset infusion resin system.

Published
2021
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23. Structural Optimization through Biomimetic-Inspired Material-Specific Application of Plant-Based Natural Fiber-Reinforced Polymer Composites (NFRP) for Future Sustainable Lightweight Architecture.

Author

Sippach T, Dahy H, Uhlig K, Grisin B, Carosella S, and Middendorf P

Abstract

Under normal conditions, the cross-sections of reinforced concrete in classic skeleton construction systems are often only partially loaded. This contributes to non-sustainable construction solutions due to an excess of material use. Novel cross-disciplinary workflows linking architects, engineers, material scientists and manufacturers could offer alternative means for more sustainable architectural applications with extra lightweight solutions. Through material-specific use of plant-based Natural Fiber-Reinforced Polymer Composites (NFRP), also named Biocomposites , a high-performance lightweight structure with topology optimized cross-sections has been here developed. The closed life cycle of NFRPs promotes sustainability in construction through energy recovery of the quickly generative biomass-based materials. The cooperative design resulted in a development that were verified through a 1:10 demonstrator, whose fibrous morphology was defined by biomimetically-inspired orthotropic tectonics, generated with by the fiber path optimization software tools, namely EdoStructure and EdoPath in combination with the appliance of the digital additive manufacturing technique: Tailored Fiber Placement (TFP).

Published
2020
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24. Curved Foldable Tailored Fiber Reinforcements for Moldless Customized Bio-Composite Structures. Proof of Concept: Biomimetic NFRP Stools.

Author

Rihaczek G, Klammer M, Başnak O, Petrš J, Grisin B, Dahy H, Carosella S, and Middendorf P

Abstract

Fiber Reinforced Polymers (FRPs) are increasingly popular building materials, mainly because of their high strength to weight ratio. Despite these beneficial properties, these composites are often fabricated in standardized mass production. This research aims to eliminate costly molds in order to simplify the fabrication and allow for a higher degree of customization. Complex three-dimensional shapes were instead achieved by a flat reinforcement, which was resin infused and curved folded into a spatial object before hardening. Structural stability was gained through geometries with closed cross-sections. To enable this, the resource-saving additive fabrication technique of tailored fiber placement (TFP) was chosen. This method allowed for precise fibers' deposition, making a programmed anisotropic behavior of the material possible. Principles regarding the fiber placement were transferred from a biological role-model. Five functional stools were produced as demonstrators to prove the functionality and advantages of the explained system. Partially bio-based materials were applied to fabricate the stool models of natural fiber-reinforced polymer composites (NFRP). A parametric design tool for the global design and fiber layout generation was developed. As a result, varieties of customized components can be produced without increasing the design and manufacturing effort.

Published
2020
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25. Switch to dolutegravir and unboosted atazanavir in HIV-1 infected patients with undetectable viral load and long exposure to antiretroviral therapy.

Author

Castagna A, Rusconi S, Gulminetti R, Bonora S, Mazzola G, Quiros-Roldan ME, De Socio GV, Ladisa N, Carosella S, Cattelan A, Di Giambenedetto S, Mena M, Poli A, Galli L, and Riva A

Subjects
Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Drug Therapy, Combination, Female, HIV-1 drug effects, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Oxazines, Piperazines, Pyridones, RNA, Viral blood, Treatment Outcome, Viral Load, Atazanavir Sulfate therapeutic use, Drug Substitution, HIV Infections drug therapy, HIV Integrase Inhibitors therapeutic use, Heterocyclic Compounds, 3-Ring therapeutic use
Abstract

: We evaluated the efficacy and safety of a two-drug regimen including dolutegravir (DTG) and unboosted atazanavir (uATV) in 151 HIV-1 infected patients with HIV-RNA of more than 50 copies/ml. During a median follow-up of 62 (42-97) weeks, two virological failures (1%) and 13 treatment discontinuations (9%) occurred; the 48-week probability of virological failure was 0.8% (95% confidence interval 0.2-5.6%). Switch to DTG + uATV may represent a boosting and transcriptase reverse inhibitors sparing otion in individuals with long exposure to antiretroviral therapy and risk of cardiovascular disease.

Published
2019
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26. Louseborne Relapsing Fever among East African Refugees, Italy, 2015.

Author

Lucchini A, Lipani F, Costa C, Scarvaglieri M, Balbiano R, Carosella S, Calcagno A, Audagnotto S, Barbui AM, Brossa S, Ghisetti V, Dal Conte I, Caramello P, and Di Perri G

Subjects
Humans, Italy epidemiology, RNA, Ribosomal, 16S genetics, Relapsing Fever diagnosis, Relapsing Fever transmission, Black People, Borrelia classification, Borrelia genetics, Borrelia isolation & purification, Refugees, Relapsing Fever epidemiology, Relapsing Fever microbiology
Abstract

During June 9-September 30, 2015, five cases of louseborne relapsing fever were identified in Turin, Italy. All 5 cases were in young refugees from Somalia, 2 of whom had lived in Italy since 2011. Our report seems to confirm the possibility of local transmission of louse-borne relapsing fever.

Published
2016
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27. Evaluation of a Cognitive Rehabilitation Protocol in HIV Patients with Associated Neurocognitive Disorders: Efficacy and Stability Over Time.

Author

Livelli A, Orofino GC, Calcagno A, Farenga M, Penoncelli D, Guastavigna M, Carosella S, Caramello P, and Pia L

Abstract

The primary aim of the present study was to evaluate the efficacy and stability over time of a cognitive rehabilitation protocol (restorative and compensatory approach) in HIV/AIDS patients with HIV-associated Neurocognitive Disorder (HAND). At baseline, 32 HIV/AIDS patients (16 with and 16 without HAND) were assessed with a neuropsychological battery (i.e., pre-assessment) consisting of 22 tests covering eight cognitive domains. Then, the experimental group was administered over 4 months a cognitive rehabilitation protocol aimed at improving four cognitive domains by means of eight paper and pencil/computer-based exercises. The control group received guideline-adherent clinical care (i.e., standard of care). At the end of the cognitive treatment, both groups were re-administered the neuropsychological battery (i.e., post-assessment). Additionally, 6 months after post-assessment, the experimental group was given the same neuropsychological battery (i.e., follow up-assessment). In order to test the efficacy of the cognitive rehabilitation protocol, we compared between groups the results of the neuropsychological battery at the pre- and post-assessments. In order to evaluate the stability over time, the effects of the cognitive rehabilitation protocol was examined comparing within the experimental group the results of the neuropsychological battery at post- and follow up-assessments. Our results show that the two groups did not differ at the pre-assessment, but differed at post-assessment. Specifically, the experimental group showed a significant improvement in five domains (Learning and memory, Abstraction/executive functioning, Verbal fluency, Attention/working memory, and Functional), whereas the control group significantly worsened in the same domains. The improvement of the experimental group did not change in the follow up-assessment in two domains (Abstraction/executive functioning, Attention/working memory, and Functional). Overall, these findings support the efficacy and, to some extent, the stability over time of our cognitive rehabilitation protocol.

Published
2015
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28. Treatment outcome in HIV+ patients receiving 3- or 4-drug regimens during PHI.

Author

Bottani GM, Oreni ML, Orofino G, Tau P, Di Nardo Stuppino S, Colella E, Carosella S, Guastavigna M, Ghisetti V, Micheli V, Galli M, and Rusconi S

Abstract

Introduction: The optimal timing and modality of therapeutic intervention during early phases of HIV infection is still debated; in our prospective observational study we evaluated immunological and virological outcome in HIV+ patients treated during acute or recent HIV infection., Materials and Methods: A total of 25 naïve patients with acute (detectable HIV-RNA, immature Western Blot) or recent (documented infection within six months) HIV infection were recruited at the Infectious Diseases Units of the University of Milan and Turin from 2009 to 2014. Patients received treatment with two NRTIs+one NNRTI/bPI, with or without an induction phase with an additional fourth drug (raltegravir or maraviroc) until HIV-RNA undetectability maintained for six months. Blood samples for HIV-RNA, lymphocyte subsets and tropism assessment were obtained at the beginning of the treatment (BL). Patients underwent subsequent six-monthly follow up for clinical outcome, CD4 cell count and HIV-RNA up to 18 months., Results: Median increase in CD4 cells from 0 to 12 months was greater in patients treated during acute (n=18) versus recent (n=7) infection [284/µL, IQR (227-456) versus 176/µL, IQR (70-235); Mann-Whitney test, p=0.046]. This higher value was maintained through 18 months, although failing to reach statistical significance. Patients with acute or recent infection did not significantly differ in virological success (83.3% versus 85.7% at 12 months). We considered CD4 cells gains at six months (multivariate analysis, ANCOVA; Figure 1) and detected an inverse correlation with CD4 levels at BL (r=-0.517; p=0.008) and a direct correlation with the status of acute infection (r=0.234, p NS). This last correlation reached statistical significance at 12 months (r=0.418, p=0.035), whereas the inverse correlation with CD4 levels at BL was still present without a statistical significance (r=-0.350; p=0.072). Patients treated with three or four drugs did not show any significant difference in immunological nor virological response (Mann-Whitney and χ(2) test). Modification or interruption of therapy for tolerability took place in 4 out of 25 patients, all while receiving four drugs; two patients underwent STI between 12 and 18 months following virological success., Conclusions: Treatment of primary infection appeared to be effective in preserving the pool of CD4 cells in acute more than recent infection. There was no evidence of a different outcome through the addition of a fourth drug to the standard treatment.

Published
2014
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29. [Primary soft tissue and tenosynovial tuberculosis after needlestick injury in a surgeon].

Author

Lipani F, Canta F, Carosella S, Marrone R, Boglione L, Sacchi C, and Caramello P

Subjects
Humans, Male, Middle Aged, Occupational Diseases diagnosis, Soft Tissue Infections diagnosis, Tuberculosis diagnosis, General Surgery, Needlestick Injuries complications, Occupational Diseases etiology, Soft Tissue Infections etiology, Tuberculosis etiology
Abstract

We describe the case of a surgeon, who pricked himself with a needle used to drain a paravertebral abscess in a patient from Sudan. He lost this patient at follow up. Six weeks later, the surgeon developed oedema of his left hand and wrist. He started antibiotics, amoxicillin/clavulanate plus ciprofloxacin 2 weeks, without any improvement. He came to our centre for examination, and by chance his patient had been admitted to our ward the day before, and had died during the night of disseminated tuberculosis. The surgeon was treated with rifampin, isoniazid and pyrazinamide (3 drugs 2 months, followed by rifampin plus isoniazid for further 7 months) with rapid improvement. He could start his job again after 5 months. To our knowledge, this is the first case of inoculation tuberculosis transmitted to a surgeon, while other cases in health care workers (internists, pathologists, nurses...) have already been well described.

Published
2008

30. 50 Hz sinusoidal magnetic fields do not affect human lymphocyte activation and proliferation in vitro.

Author

Capri M, Mesirca P, Remondini D, Carosella S, Pasi S, Castellani G, Franceschi C, and Bersani F

Subjects
Adult, Aged, Cell Cycle, Flow Cytometry, Humans, Phenotype, Cell Proliferation radiation effects, Lymphocyte Activation radiation effects, Magnetics
Abstract

In the last 30 years, an increasing public concern about the possible harmful effects of electromagnetic fields generated by power lines and domestic appliances has pushed the scientific community to search for a correct and comprehensive answer to this problem. In this work the effects of exposure to 50 Hz sinusoidal magnetic fields, with a magnetic flux density of 0.05 mT and 2.5 mT (peak values), were studied on human peripheral blood mononuclear cells (PBMCs) collected from healthy young and elderly donors. Cell activation and proliferation were investigated by using flow cytometry techniques and 3H-TdR incorporation assays, respectively. The results obtained indicated that exposure to the fields altered neither DNA synthesis nor the capacity of lymphocytes to enter the activation phase and progress into the cell cycle. Thus, the conclusions are that two important functional phases of human lymphocytes, such as activation and proliferation, are not affected by exposures to 50 Hz magnetic fields similar to those found under power lines.

Published
2004
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