Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials
Roy T Steigbigel, David A Cooper, Hedy Teppler, Joseph J Eron, Jose M Gatell, Princy N Kumar, Jurgen K Rockstroh, Mauro Schechter, Christine Katlama, Martin Markowitz, Patrick Yeni, Mona R Loutfy, Adriano Lazzarin, Jeffrey L Lennox, Bonaventura Clotet, Jing Zhao, Hong Wan, Rand R Rhodes, Kim M Strohmaier, Richard J Barnard, Robin D Isaacs, Bach-Yen T Nguyen, BENCHMRK Study Teamsa, A Allworth, J Anderson, M Bloch, D A Cooper, J Hoy, C Workman, N Clumeck, R Colebunders, M Moutschen, J Gerstoft, C Larsen, L Mathiesen, C Pedersen, J F Delfraissy, P Dellamonica, C Katlama, J M Molina, F Raffi, J Reynes, D Vittecoq, P Yeni, K Arasteh, G Fatkenheuer, H Jaeger, J Rockstroh, A Stoehr, F Aiuti, G Carosi, R Cauda, F Chiodo, G Di Perri, G Filice, M Galli, A Lazzarin, V Vullo, M Castaneda, A Florez, F Mendo, A Paredes, R Salazar, E Ticona, R Antunes, A Diniz, K Mansinho, J Saraiva da Cunha, R Sarmento, E Teofilo, J Vera, J Arrizabalaga, B Clotet, P Domingo Pedrol, J GatellArtigas, S Moreno Guillen, V Soriano Vazquez, B Hirschel, M Opravil, H-H Lin, W H Sheng, J H Wang, S Sungkanuparph, S Suwanagool, B Grinsztejn, J V Madruga, M Schecter, J -G Baril, M R Loutfy, J S Montaner, C Tremblay, C M Tsoukas, S Vezina, J A Cortes, H Mendoza, J Velez, N Quintero Perez, J Ramos, E Rodriguez, J O Morales-Ramirez, G E Sepulveda, J Aberg, G W Beatty, P Benson, R K Bolon, U F Bredeek, C Bruno, T Campbell, R Campo, G O Coodley, R B Corales, E DeJesus, J J Eron, W J Fessel, R J Fetchick, J Gonzalez, C Hicks, M A Horberg, D B Klein, M J Kozal, P N Kumar, A LaMarca, J L Lennox, K A Lichtenstein, R Liporace, S J Little, A Luetkemeyer, F Mariuz, M Markowitz, D K McMahon, G Perez, G Pierone, R C Reichman, F Rhame, P Shalit, P Sklar, W Short, P R Skolnik, R T Steigbigel, E M Tedaldi, D J Ward, A A Wiznia, D P Wright, Roy T Steigbigel, David A Cooper, Hedy Teppler, Joseph J Eron, Jose M Gatell, Princy N Kumar, Jurgen K Rockstroh, Mauro Schechter, Christine Katlama, Martin Markowitz, Patrick Yeni, Mona R Loutfy, Adriano Lazzarin, Jeffrey L Lennox, Bonaventura Clotet, Jing Zhao, Hong Wan, Rand R Rhodes, Kim M Strohmaier, Richard J Barnard, Robin D Isaacs, Bach-Yen T Nguyen, BENCHMRK Study Teamsa, A Allworth, J Anderson, M Bloch, D A Cooper, J Hoy, C Workman, N Clumeck, R Colebunders, M Moutschen, J Gerstoft, C Larsen, L Mathiesen, C Pedersen, J F Delfraissy, P Dellamonica, C Katlama, J M Molina, F Raffi, J Reynes, D Vittecoq, P Yeni, K Arasteh, G Fatkenheuer, H Jaeger, J Rockstroh, A Stoehr, F Aiuti, G Carosi, R Cauda, F Chiodo, G Di Perri, G Filice, M Galli, A Lazzarin, V Vullo, M Castaneda, A Florez, F Mendo, A Paredes, R Salazar, E Ticona, R Antunes, A Diniz, K Mansinho, J Saraiva da Cunha, R Sarmento, E Teofilo, J Vera, J Arrizabalaga, B Clotet, P Domingo Pedrol, J GatellArtigas, S Moreno Guillen, V Soriano Vazquez, B Hirschel, M Opravil, H-H Lin, W H Sheng, J H Wang, S Sungkanuparph, S Suwanagool, B Grinsztejn, J V Madruga, M Schecter, J -G Baril, M R Loutfy, J S Montaner, C Tremblay, C M Tsoukas, S Vezina, J A Cortes, H Mendoza, J Velez, N Quintero Perez, J Ramos, E Rodriguez, J O Morales-Ramirez, G E Sepulveda, J Aberg, G W Beatty, P Benson, R K Bolon, U F Bredeek, C Bruno, T Campbell, R Campo, G O Coodley, R B Corales, E DeJesus, J J Eron, W J Fessel, R J Fetchick, J Gonzalez, C Hicks, M A Horberg, D B Klein, M J Kozal, P N Kumar, A LaMarca, J L Lennox, K A Lichtenstein, R Liporace, S J Little, A Luetkemeyer, F Mariuz, M Markowitz, D K McMahon, G Perez, G Pierone, R C Reichman, F Rhame, P Shalit, P Sklar, W Short, P R Skolnik, R T Steigbigel, E M Tedaldi, D J Ward, A A Wiznia, D P Wright
Abstract
BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.
Conflict of interest statement
Potential conflicts of interest. R.T.S. has received research support, speaker fees, and/or consulting fees from Merck. D.A.C. has received research support, speaker fees, and/or consulting fees from Merck. J.J.E. has received research support from Merck, Abbott, and Panacos and speaker fees and/or consulting fees from Merck, BMS, GSK, Gilead, Tibotec, Roche, and Pfizer. J.M.G. has received research support, speaker fees, and consulting fees from Merck. P.N.K. has been an investigator for Merck and GSK; has been a paid consultant to Boehringer-Ingelheim, BMS, GSK, and Tibotec; and has received speaker fees from GSK, Abbott, Tibotec, Pfizer, and Boehringer-Ingelheim. J.K.R. has received honoraria for lectures or advisory boards from Merck, Roche, GSK, BMS, Tibotec, Pfizer, Gilead, Abbott, and Boehringer Ingelheim. C.K. has received honoraria for advisory boards or lectures from Merck, Gilead, Roche, GSK, Tibotec, BMS, and Boehringer Ingelheim. M.M. has received research support, speaker fees, and/or consulting fees from Merck. P.Y. has received consulting fees from Merck. M.R.L. has received research support from Merck. A.L. has received honoraria for lectures or advisory board meetings and/or research support from Merck, GSK, BMS, Gilead, Roche, Tibotec, Pfizer, Boehringer-Ingelheim, Abbott, Monogram, and Schering-Plough. J.L.L. has received research support and speaker’s fees from Merck and serves on Merck’s antiretroviral scientific advisory board. B.C. has been a consultant on advisory boards, has participated in speakers’ bureaus, or has conducted clinical trials with Roche, Boehringer-Ingelheim, Abbott, BMS, GSK, Gilead, Tibotec, Janssen, Merck, Pfizer, Siemens, Monogram Biosciences, and Panacos. H.T., M.S., H.W., R.R.R., K.M.S., R.J.B., R.D.I., and B.-Y.T.N.are employees of Merck Research Laboratories and may own stock and/or stock options in the company.
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Source: PubMed