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9 results on '"Mezzaroma I"'

1. 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

2. 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

3. 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

4. Altered clonogenic capability and stromal cell function characterize bone marrow of HIV-infected subjects with low CD4+ T cell counts despite viral suppression during HAART.

Author

Isgrò A, Leti W, De Santis W, Marziali M, Esposito A, Fimiani C, Luzi G, Pinti M, Cossarizza A, Aiuti F, and Mezzaroma I

Subjects
Adult, Aged, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Fas Ligand Protein biosynthesis, Female, HIV Infections drug therapy, HIV-1 drug effects, Hematopoietic Stem Cells, Humans, Interleukin-2 biosynthesis, Interleukin-7 biosynthesis, Male, Middle Aged, RNA, Viral blood, Stromal Cells immunology, Tumor Necrosis Factor-alpha biosynthesis, fas Receptor biosynthesis, Bone Marrow immunology, CD4-Positive T-Lymphocytes immunology, HIV Infections immunology, HIV Infections virology, Lymphopoiesis immunology, Viral Load
Abstract

Background: Inflammatory cytokines in bone marrow may impair hematolymphopoiesis in human immunodeficiency virus (HIV)-infected subjects who do not experience reconstitution of CD4(+) T cells despite suppression of virus replication while receiving highly active antiretroviral therapy (HAART) (immunological nonresponders)., Methods: Bone marrow samples from 12 immunological nonresponders receiving HAART were studied and compared with samples from 11 immunological responders. The mean CD4(+) T cell count (+/- standard deviation) was 174 +/- 68 cells/mm(3) and plasma HIV RNA levels had been <50 copies/mL for at least 1 year for individuals enrolled in the study. The clonogenic capability of bone marrow samples was evaluated using the colony forming cell assay and the long-term culture-initiating cell assay. CD34(+) cells from the colony forming cell assay were pooled for real-time polymerase chain reaction analysis of Fas and Fas ligand. Bone marrow cytokine production (interleukin-2 and tumor necrosis factor-alpha) and stromal interleukin-7 levels were analyzed by enzyme-linked immunosorbent assay in both groups. Flow cytometric analysis of CD4(+) and CD8(+) T cell subsets was performed., Results: A reduced clonogenic capability and a decrease in the level of more primitive progenitor cells were observed in parallel with lower production of interleukin-2 and increased tumor necrosis factor-alpha levels. A significant upregulation of Fas and Fas ligand on CD34(+) cells and a higher stromal interleukin-7 production were observed. Impairment of the naive T cell compartment and persistent T cell activation were observed in peripheral blood., Conclusions: Samples from immunological nonresponders show reduced growth of in vitro colonies and an altered cytokine production in bone marrow. The cytokine pattern observed and the altered Fas and Fas ligand pathway may determine stem cell apoptosis and low CD4(+) cell recovery. These features, which are similar to those observed in HIV-infected subjects before starting therapy, persist despite treatment.

Published
2008
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5. Comparison of a rule-based algorithm with a phenotype-based algorithm for the interpretation of HIV genotypes in guiding salvage regimens in HIV-infected patients by a randomized clinical trial: the mutations and salvage study.

Author

Gianotti N, Mondino V, Rossi MC, Chiesa E, Mezzaroma I, Ladisa N, Guaraldi G, Torti C, Tarquini P, Castelli P, Di Carlo A, Boeri E, Keulen W, Kenna PM, and Lazzarin A

Subjects
Adult, Antiretroviral Therapy, Highly Active, Female, Genotype, HIV Protease Inhibitors therapeutic use, Humans, Italy, Male, Middle Aged, Phenotype, RNA, Viral blood, RNA, Viral genetics, Reverse Transcriptase Inhibitors therapeutic use, Viral Load, Algorithms, Anti-HIV Agents therapeutic use, HIV genetics, HIV Infections drug therapy, Mutation, Salvage Therapy
Abstract

Background: There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results., Methods: A total of 318 subjects with HIV RNA levels of >1000 copies/mL were enrolled in 41 centers throughout Italy from 2001 through 2003, stratified on the basis of their drug history, randomized (1:1) to 2 arms to have their treatments modified on the basis of the results of HIV genotyping (as interpreted by virtual phenotype analysis or with use of a rule-based interpretation system), and followed up for 48 weeks. At least 1 nucleoside reverse-transcriptase inhibitor and 1 protease inhibitor had to be included in any new regimen; nonnucleoside reverse-transcriptase inhibitor-naive patients were also prescribed a nonnucleoside reverse-transcriptase inhibitor. Only drugs licensed in Italy were allowed. The primary end point was a decrease in HIV RNA level to <400 copies/mL by week 12 according to on-treatment analysis., Results: The mean (+/- standard deviation) values at baseline were as follows: HIV RNA level, 4.1+/-0.74 log(10) copies/mL; CD4(+) T lymphocyte count, 410+/-262 cells/microL; reverse-transcriptase mutations, 4.8+/-2.9; and protease mutations, 2.8+/-2.5. There were 133 patients (41.8%) who were nonnucleoside reverse-transcriptase inhibitor naive and protease inhibitor experienced, 63 patients (19.8%) who were nonnucleoside reverse-transcriptase inhibitor experienced and protease inhibitor naive, and 122 patients (38.4%) who were 3-class experienced. A total of 192 patients completed 12 weeks of the treatment regimen assigned at baseline; at 12 weeks, 66.3% of patients in the virtual phenotype arm and 71.3% of patients in the rule-based interpretation arm had HIV RNA levels of <400 copies/mL (P = .46). No statistically significant difference between arms was observed by intention-to-treat analysis., Conclusion: Both the virtual phenotype and rule-based interpretation methods of HIV genotyping can guide the selection of effective antiretroviral drugs for a salvage regimen.

Published
2006
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6. Assessment of thymic output in common variable immunodeficiency patients by evaluation of T cell receptor excision circles.

Author

Guazzi V, Aiuti F, Mezzaroma I, Mazzetta F, Andolfi G, Mortellaro A, Pierdominici M, Fantini R, Marziali M, and Aiuti A

Subjects
Adult, Biomarkers, CD4-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes immunology, Case-Control Studies, Common Variable Immunodeficiency genetics, Female, Gene Rearrangement, T-Lymphocyte, Humans, L-Selectin metabolism, Leukocyte Common Antigens metabolism, Male, Middle Aged, Thymus Gland immunology, Common Variable Immunodeficiency immunology, Receptors, Antigen, T-Cell metabolism, T-Lymphocyte Subsets immunology
Abstract

Common variable immunodeficiency (CVID) is a heterogeneous syndrome characterized by repeated infections and hypogammaglobulinaemia. Additionally, T-cell abnormalities including lymphopenia, decreased proliferation to mitogens and antigens, and the reduced production and expression of cytokines, have also been observed. In this study we have investigated the expression of naive, memory and activation markers in T-cell subpopulations in 17 CVID patients in comparison to age-matched normal controls. The numbers of CD4+ T cells, including CD45RA+CD62L+ and, to a lesser extent, CD45RA-CD62L+/RA+CD62L- were significantly reduced in patients, whereas CD8+ T cells were within normal range. In contrast, HLA-DR+ cells were increased both in CD4+ and CD8+ T cells. To assess the thymic output, we analysed the presence of T-cell receptor excision circles (TRECs) in CD4+ and CD8+ T cells by quantitative PCR. TRECs were decreased significantly in patients and the rate of TREC loss was higher with increasing age. TRECs correlated with naive CD4+ T cells, whereas there was an inverse relationship between TRECs and CD8+HLA-DR+ and CD8+CD45RA-CD62L+/RA+CD62L- T cells. Our results suggest the presence of a defect in the naive T cell compartment with origin at the thymic level in CVID, and indicate that TREC may be a useful marker to monitor thymic function in this primary immunodeficiency.

Published
2002
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7. Clinical and immunologic response without decrease in virus load in patients with AIDS after 24 months of highly active antiretroviral therapy.

Author

Mezzaroma I, Carlesimo M, Pinter E, Muratori DS, Di Sora F, Chiarotti F, Cunsolo MG, Sacco G, and Aiuti F

Subjects
AIDS-Related Opportunistic Infections prevention & control, Acquired Immunodeficiency Syndrome immunology, Acquired Immunodeficiency Syndrome mortality, Adult, CD4-Positive T-Lymphocytes cytology, CD4-Positive T-Lymphocytes drug effects, Clinical Trials as Topic, Drug Therapy, Combination, Female, Follow-Up Studies, HIV Infections drug therapy, HIV Infections immunology, HIV Infections mortality, HIV Protease Inhibitors therapeutic use, HIV-1 drug effects, HIV-1 genetics, Humans, Logistic Models, Lymphocyte Count drug effects, Male, Middle Aged, RNA, Viral blood, RNA, Viral drug effects, Retrospective Studies, Reverse Transcriptase Inhibitors therapeutic use, Survival Analysis, T-Lymphocytes cytology, T-Lymphocytes drug effects, T-Lymphocytes immunology, Time Factors, Treatment Outcome, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use, Viral Load
Abstract

This study reports an analysis of clinical, virological, and immunologic outcomes in a cohort of 77 multidrug-experienced AIDS patients during 24 months of highly active antiretroviral therapy (HAART). Our results have shown a reduced risk of AIDS complications, prolonged survival, and immunologic benefit even in the absence of sustained virus suppression. The degree of immunodepression, the risk factors for HIV-1 infection, the use of 2 drugs instead of 3, and a change in protease inhibitor were independently correlated with virological failure. In the majority of studied patients, an increase in CD4+ T cells was observed after HAART. However, the increase was more pronounced in patients who showed a decrease in virus load than in those who did not. Moreover, we observed an absence of relapses among patients who permanently discontinued prophylaxis for Cytomegalovirus retinitis and atypical mycobacterial infections. Peripheral lipodystrophy developed in the majority of patients, regardless of treatment used and virological outcome.

Published
1999
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8. Responsiveness of human polymorphonuclear cells (PMNL) to stimulation by a mannoprotein fraction (MP-F2) of Candida albicans; enhanced production of IL-6 and tumour necrosis factor-alpha (TNF-alpha) by MP-F2-stimulated PMNL from HIV-infected subjects.

Author

Torosantucci A, Chiani P, Quinti I, Ausiello CM, Mezzaroma I, and Cassone A

Subjects
Adult, Candida albicans immunology, Cells, Cultured, Female, Fungal Proteins pharmacology, HIV Infections metabolism, Humans, Interleukin-1 biosynthesis, Interleukin-10 pharmacology, Interleukin-8 biosynthesis, Male, Membrane Glycoproteins pharmacology, Middle Aged, Neutrophil Activation drug effects, Neutrophils drug effects, Neutrophils metabolism, Peptide Fragments pharmacology, Fungal Proteins immunology, HIV Infections immunology, Interleukin-6 biosynthesis, Membrane Glycoproteins immunology, Neutrophil Activation immunology, Neutrophils microbiology, Peptide Fragments immunology, Tumor Necrosis Factor-alpha biosynthesis
Abstract

IL-1beta, IL-6, IL-8 and TNF-alpha production by PMNL from 21 HIV-infected (HIV+), including 11 full-blown AIDS, and 20 HIV-uninfected (HIV-) subjects (matched for age and sex to HIV+ ones) was studied by reverse transcriptase-polymerase chain reaction (RT-PCR) and ELISA. PMNL from both categories of subjects were strongly stimulated in their actual cytokine production by a mannoprotein fraction (MP-F2) of Candida albicans, as well as by the bacterial lipopolysaccharide (LPS). These stimulatory effects were apparently due to increased cytokine gene expression and were substantially reversed by the physiological inhibitor IL-10. However, PMNL from HIV+ subjects showed increased IL-6 and TNF-alpha gene expression and produced more IL-6 and TNF-alpha than PMNL from HIV- controls, under similar stimulation conditions. This difference could not be attributed to a given stage of HIV infection, any associated medication, or to a generalized increase of gene expression, as quantitatively similar beta-actin and IL-1beta transcripts were detected. Moreover, no significant difference in IL-8 production by the PMNL from HIV+ and HIV- subjects was observed. Our studies suggest that PMNL from HIV+ subjects might add to other cellular sources of IL-6 and TNF-alpha (e.g. monocytes-macrophages) in contributing to the cytokine-dysregulated pattern typical of the HIV+ patient.

Published
1997
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9. Proliferative and cytotoxic responses to mannoproteins of Candida albicans by peripheral blood lymphocytes of HIV-infected subjects.

Author

Quinti I, Palma C, Guerra EC, Gomez MJ, Mezzaroma I, Aiuti F, and Cassone A

Subjects
Adolescent, Adult, Antibody Formation, Female, Humans, Male, Mannose-Binding Lectins, Middle Aged, Acquired Immunodeficiency Syndrome immunology, Antigens, Fungal immunology, Candida albicans immunology, Carrier Proteins immunology, HIV-1
Abstract

Mucosal candidiasis is one of the first opportunistic diseases in HIV-infected subjects. In order to understand the relationship between this disease and immunodeficiency to chemically defined, immunodominant Candida antigens, a mannoprotein fraction from C. albicans cell wall (GMP) was used to analyse proliferative and non-MHC-restricted cytotoxic responses of peripheral blood mononuclear cells (PBMC) from normal and HIV-infected subjects. In the former, GMP induced extensive blastogenesis, generation of powerful cytotoxicity against a tumour cell line (K562), and production of substantial amounts of interferon-gamma (IFN-gamma). Cultured PBMC from HIV-infected subjects manifested an early decreased ability for proliferative as well as differentiative cytotoxic responses to the candidal mannoproteins. This inability became clearly evident in subjects with stage III (CDC) of the disease, was total in CDC stage IV and occurred even in some subjects with a normal number of CD4+ cells. Low or absent response to GMP correlated with lack of response to tetanus toxoid. In contrast, both lymphoproliferative and cytotoxic responses to exogenous IL-2 was highly preserved at all stages of infection. The production of IFN-gamma in GMP-stimulated PBMC cultures critically fell to negligible values in most of the subjects in CDC stages II and III. Thus, the lowered or absent cell-mediated immune responses to candidal mannoprotein may be one factor to explain the early, elevated susceptibility of HIV-infected subjects to mucosal candidiasis. This study also shows that our mannoprotein preparation may be used as a probe to detect the overall efficiency of T cell responses in the above subjects.

Published
1991
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