Raltegravir with optimized background therapy for resistant HIV-1 infection

Roy T. Steigbigel, David A. Cooper, Princy N. Kumar, Joseph E. Eron, Mauro Schechter, Martin Markowitz, Mona R. Loutfy, Jeffrey L. Lennox, Jose M. Gatell, Jurgen K. Rockstroh, Christine Katlama, Patrick Yeni, Adriano Lazzarin, Bonaventura Clotet, Jing Zhao, Joshua Chen, Desmond M. Ryan, Rand R. Rhodes, John A. Killar, Lucinda R. GildeKim M. Strohmaier, Anne R. Meibohm, Michael D. Miller, Daria J. Hazuda, Michael L. Nessly, Mark J. DiNubile, Robin D. Isaacs, Bach Yen Nguyen, Hedy Teppler

Research output: Contribution to journalArticle


BACKGROUND: Raltegravir (MK-0518) is an inhibitor of human immunodeficiency virus type 1 (HIV-1) integrase active against HIV-1 susceptible or resistant to older antiretroviral drugs. METHODS: We conducted two identical trials in different geographic regions to evaluate the safety and efficacy of raltegravir, as compared with placebo, in combination with optimized background therapy, in patients infected with HIV-1 that has triple-class drug resistance in whom antiretroviral therapy had failed. Patients were randomly assigned to raltegravir or placebo in a 2:1 ratio. RESULTS: In the combined studies, 699 of 703 randomized patients (462 and 237 in the raltegravir and placebo groups, respectively) received the study drug. Seventeen of the 699 patients (2.4%) discontinued the study before week 16. Discontinuation was related to the study treatment in 13 of these 17 patients: 7 of the 462 raltegravir recipients (1.5%) and 6 of the 237 placebo recipients (2.5%). The results of the two studies were consistent. At week 16, counting noncompletion as treatment failure, 355 of 458 raltegravir recipients (77.5%) had HIV-1 RNA levels below 400 copies per milliliter, as compared with 99 of 236 placebo recipients (41.9%, P

Original languageEnglish
Pages (from-to)339-354
Number of pages16
JournalNew England Journal of Medicine
Issue number4
Publication statusPublished - Jul 24 2008


ASJC Scopus subject areas

  • Medicine(all)

Cite this

Steigbigel, R. T., Cooper, D. A., Kumar, P. N., Eron, J. E., Schechter, M., Markowitz, M., Loutfy, M. R., Lennox, J. L., Gatell, J. M., Rockstroh, J. K., Katlama, C., Yeni, P., Lazzarin, A., Clotet, B., Zhao, J., Chen, J., Ryan, D. M., Rhodes, R. R., Killar, J. A., ... Teppler, H. (2008). Raltegravir with optimized background therapy for resistant HIV-1 infection. New England Journal of Medicine, 359(4), 339-354. https://doi.org/10.1056/NEJMoa0708975