1. Comparison of dual nucleoside-analogue reverse-transcriptase inhibitor regimens with HIV-1 who have not previously been treated: the PENTA 5 randomized trial
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J. P. Aboulker, A. Babiker, A. Compagnucci, J. H. Darbyshire, M. Debré, C. Giaquinto, D. M. Gibb, L. Harper, Y. Saidi, AS Walker, J. Darbyshire, D. Johnson, P. Kelleher, L. McGee, A Newberry, A. Poland, A. S. Walker, J P. Aboulker, I. Carrière, V. Eliette, S. Leonardo, M. Gersten, A. Jones, S. Blanche, A. B. Bohlin, K Butler, G. Castelli Gattinara, P. Clayden, R De Groot, A. Faye, C. Griscelli, I Grosch Wörner, C. Kind, H. Lyall, J. Levy, M. Mellado Pena, D. Nadal, C Peckham, J. T. Ramos Amador, L. Rosado, C. Rudin, H. Scherpbier, M Sharland, P. A. Tovo, G. Tudor Williams, N. Valerius, A. Volny Anne, U Wintergerst, V. Wahn, C. Hill, P Lepage, A. Pozniak, S. Vella, M. Hainaut, A. Peltier, S. Carlier, G. Zissis, M. Della Negra, W. Queiroz, L. P. Feitosa, D Oliveira, F. Mechinaud, F. Ballerau, A. Lepelletier, S. Billaudel, V. Ferre, I. Grosch Wörner, R. Weigel, K. Seel, C. Feiterna Sperling, D. Ohlendorf, G. Riße, C. Müller, T. Niehues, J. Ndagijimana, G. Horneff, N. Vente, R. Ganschow, T. Simon, R. Vossen, H Pfister, U. Wintergerst, G. Notheis, G. Strotmann, S Schlieben, K. Butler, E. Hayes, M. O’Mara, J. Fanning, F. Goggins, S. Moriarty, M. Byrne, L. Battisti, M. Duse, S. Timpano, E. Uberti, P. Crispino, P. Carrara, F. Fomia, A. Manca, L. Galli, M. de Martino, F. Fioredda, E. Pontali, M. Cellini, C. Baraldi, M. Portolani, M. Meacci, P. Pietrosemoli, R. Berni Canani, P. Laccetti, M. Gobbo, V. Giacomet, R. D’Elia, O. Rampon, E. Ruga, A. de Rossi, M. Zanchetta, D. Caselli, A. Maccabruni, E. Cattaneo, V Landini, S. Bernardi, A. Krzysztofiak, C. Tancredi, P. Rossi, L. Pansani, E. Palomba, C. Gabiano, A. Mazza, G. Rossetti, R. Nicolin, A. Timillero, F. Candeias, G Santos, M. L. Ramos Ribeiro, M. C. Almeida, M. H. Lourenço, R. Antunes, M. J. Mellado Pena, M L. Carillo de Albornoz, P. Martinez Santos, L. Ciria Calavia, J. Serra Devecchi, O. Delgado, N. Matamoros, A. Foot, H. Kershaw, C. Kelly, O. Caul, W. Tarnow Mordi, J. Petrie, A. McDowell, P. McIntyre, K. Appleyard, K. Sloper, V. Shah, K. Cheema, A. Aali, J. Mok, R. Russell, A. Brewster, N. Richardson, S. Burns, D. Gibb, V. Novelli, N. Klein, S. Ewen, V. Yeung, C. Ball, K. Himid, D. Nayagam, D. Graham, A. Barrie, K. Stringer, S. Jones, N. Weerasooriya, M. Zuckerman, P. Bracken, E. Cooper, T. Fisher, R. Barrie, U. Patel, V. Van Someren, K. Moshal, L. Perry, T. Gundlach, J. Norman, M. Sharland, M. Richardson, S. Donaghy, Z. Mitchla, C. Wells, J. Booth, A. Shipp, J. White, S. Head, S. Lambers, K. O’Hara, C. Stainsby, G. Du Mont, T. Solanki, S. Swanton, S. O’Shea, A. Tilsey, S. Kaye, A. Finn, S. Choo, R. Lakshman, L. Barr, G. Bell, A. Siddens, GUARINO, ALFREDO, SPAGNUOLO, MARIA IMMACOLATA, Aboulker, J. P., Babiker, A., Compagnucci, A., Darbyshire, J. H., Debré, M., Giaquinto, C., Gibb, D. M., Harper, L., Saidi, Y., Walker, A, Darbyshire, J., Johnson, D., Kelleher, P., Mcgee, L., Newberry, A, Poland, A., Walker, A. S., Aboulker, J P., Carrière, I., Eliette, V., Leonardo, S., Gersten, M., Jones, A., Blanche, S., Bohlin, A. B., Butler, K, Castelli Gattinara, G., Clayden, P., R De Groot, Faye, A., Griscelli, C., I Grosch Wörner, Kind, C., Lyall, H., Levy, J., Mellado Pena, M., Nadal, D., Peckham, C, Ramos Amador, J. T., Rosado, L., Rudin, C., Scherpbier, H., Sharland, M, Tovo, P. A., Tudor Williams, G., Valerius, N., Volny Anne, A., Wintergerst, U, Wahn, V., Hill, C., Lepage, P, Pozniak, A., Vella, S., Hainaut, M., Peltier, A., Carlier, S., Zissis, G., Della Negra, M., Queiroz, W., Feitosa, L. P., Oliveira, D, Mechinaud, F., Ballerau, F., Lepelletier, A., Billaudel, S., Ferre, V., Grosch Wörner, I., Weigel, R., Seel, K., Feiterna Sperling, C., Ohlendorf, D., Riße, G., Müller, C., Niehues, T., Ndagijimana, J., Horneff, G., Vente, N., Ganschow, R., Simon, T., Vossen, R., Pfister, H, Wintergerst, U., Notheis, G., Strotmann, G., Schlieben, S, Butler, K., Hayes, E., O’Mara, M., Fanning, J., Goggins, F., Moriarty, S., Byrne, M., Battisti, L., Duse, M., Timpano, S., Uberti, E., Crispino, P., Carrara, P., Fomia, F., Manca, A., Galli, L., de Martino, M., Fioredda, F., Pontali, E., Cellini, M., Baraldi, C., Portolani, M., Meacci, M., Pietrosemoli, P., Guarino, Alfredo, Spagnuolo, MARIA IMMACOLATA, Berni Canani, R., Laccetti, P., Gobbo, M., Giacomet, V., D’Elia, R., Rampon, O., Ruga, E., de Rossi, A., Zanchetta, M., Caselli, D., Maccabruni, A., Cattaneo, E., Landini, V, Bernardi, S., Krzysztofiak, A., Tancredi, C., Rossi, P., Pansani, L., Palomba, E., Gabiano, C., Mazza, A., Rossetti, G., Nicolin, R., Timillero, A., Candeias, F., Santos, G, Ramos Ribeiro, M. L., Almeida, M. C., Lourenço, M. H., Antunes, R., Mellado Pena, M. J., Carillo de Albornoz, M L., Martinez Santos, P., Ciria Calavia, L., Serra Devecchi, J., Delgado, O., Matamoros, N., Foot, A., Kershaw, H., Kelly, C., Caul, O., Tarnow Mordi, W., Petrie, J., Mcdowell, A., Mcintyre, P., Appleyard, K., Sloper, K., Shah, V., Cheema, K., Aali, A., Mok, J., Russell, R., Brewster, A., Richardson, N., Burns, S., Gibb, D., Novelli, V., Klein, N., Ewen, S., Yeung, V., Ball, C., Himid, K., Nayagam, D., Graham, D., Barrie, A., Stringer, K., Jones, S., Weerasooriya, N., Zuckerman, M., Bracken, P., Cooper, E., Fisher, T., Barrie, R., Patel, U., Van Someren, V., Moshal, K., Perry, L., Gundlach, T., Norman, J., Sharland, M., Richardson, M., Donaghy, S., Mitchla, Z., Wells, C., Booth, J., Shipp, A., White, J., Head, S., Lambers, S., O’Hara, K., Stainsby, C., Du Mont, G., Solanki, T., Swanton, S., O’Shea, S., Tilsey, A., Kaye, S., Finn, A., Choo, S., Lakshman, R., Barr, L., Bell, G., and Siddens, A.
- Abstract
Introduction Treatment options for children with HIV-1 are limited. We aimed to compare activity and safety of three dualnucleoside analogue reverse-transcriptase inhibitor (NRTI) regimens with or without a protease inhibitor in previously untreated children with HIV-1. Methods In our multicentre trial, we randomly assigned 36 children to zidovudine and lamivudine, 45 to zidovudine and abacavir, and 47 to lamivudine and abacavir. Children who were symptomfree (n=55) were also randomly assigned to receive nelfinavir or placebo. Children with more advanced disease received open-label nelfinavir (73). Primary endpoints were change in plasma HIV-1 RNA at 24 and 48 weeks for the NRTI comparison and occurrence of serious adverse events for both randomised comparisons. Analyses were by intention to treat. Findings Children had a median CD4 percentage of 22% (IQR 15–29) and a mean HIV-1 RNA concentration of 5·0 log copies/mL (SD 0·8). One child was lost to follow-up and one died of sepsis. At 48 weeks, in the zidovudine/lamivudine, zidovudine/abacavir, and lamivudine/abacavir groups, mean HIV-1 RNA had decreased by 1·71, 2·19, and 2·63 log copies/mL, respectively (estimated in absence of nelfinavir) (p=0·02 after adjustment for baseline factors). One child had a hypersensitivity reaction to abacavir; and three with possible reactions stopped abacavir. There were 24 serious adverse events—six in the symptom-free children (all on nelfinavir), but none were attributed to nelfinavir. Interpretation Regimens containing abacavir were more effective than zidovudine/lamivudine. Such regimens could be combined with protease inhibitors and non-nucleoside reverse transcriptase inhibitors for safe and effective treatment of previously untreated children with HIV-1.
- Published
- 2002