Raltegravir with optimized background therapy for resistant HIV-1 infection
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2008 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/30576 |
Resumo: | Presente no BENCHMRK Study Teams: Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. |
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Steigbigel, Roy T.Cooper, David A.Kumar, Princy N.Eron, Joseph E.Schechter, MauroMarkowitz, MartinLoutfy, Mona R.Lennox, Jeffrey L.Gatell, Jose M.Rockstroh, Jurgen K.Katlama, ChristineYeni, PatrickLazzarin, AdrianoClotet, BonaventuraZhao, JingChen, JoshuaRyan, Desmond M.Rhodes, Rand R.Killar, John A.Gilde, Lucinda R.Strohmaier, Kim M.Meibohm, Anne R.Miller, Michael D.Hazuda, Daria J.Nessly, Michael L.DiNubile, Mark J.Isaacs, Robin D.Nguyen, Bach-YenTeppler, Hedy2018-12-13T14:50:15Z2018-12-13T14:50:15Z2008STEIGBIGEL, Roy T. et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. New England Journal of Medicine, v. 359, n. 4, p. 339-354, 2008.0028-4793https://www.arca.fiocruz.br/handle/icict/3057610.1056/NEJMoa0708975Presente no BENCHMRK Study Teams: Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.State University of New York at Stony Brook. Stony Brook, USA.University of New South Wales. National Centre in HIV Epidemiology and Clinical Research. Sydney, Australia.Georgetown University Medical Center. Washington, DC, USA.University of North Carolina. Chapel Hill, USA.Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.Rockefeller University. Aaron Diamond Research Center. New York, USA.University of Toronto. Toronto, Canada.Emory University. School of Medicine. Atlanta, Georgia, USA.Universitat de Barcelona. Barcelona, España.University of Bonn. Bonn, Germany.Université Pierre et Marie Curie. Hospital Pitié–Salpêtrière. Paris.Hospital Bichat–Claude Bernard. Paris.San Raffaele Scientific Institute. Milan, Italy.Fundación Irsicaixa. Hospital Germans Trias i Pujol. Barcelona, España.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.Merck Research Laboratories. North Wales, PA, USA.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<0.001). Suppression of HIV-1 RNA to a level below 50 copies per milliliter was achieved at week 16 in 61.8% of the raltegravir recipients, as compared with 34.7% of placebo recipients, and at week 48 in 62.1% as compared with 32.9% (P<0.001 for both comparisons). Without adjustment for the length of follow-up, cancers were detected in 3.5% of raltegravir recipients and in 1.7% of placebo recipients. The overall frequencies of drug-related adverse events were similar in the raltegravir and placebo groups. Conclusions: In HIV-infected patients with limited treatment options, raltegravir plus optimized background therapy provided better viral suppression than optimized background therapy alone for at least 48 weeks. (ClinicalTrials.gov numbers, NCT00293267 and NCT00293254.).engMassachusetts Medical SocietyRaltegravir with optimized background therapy for resistant HIV-1 infectioninfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHIVRaltegravirDrug ResistanceDrug TherapyAntiretroviral effectinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/30576/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALRaltegravir with optimized background_Beatriz_Grinsztejn_INI_Lapclin-AIDS_2008.pdfRaltegravir with optimized background_Beatriz_Grinsztejn_INI_Lapclin-AIDS_2008.pdfapplication/pdf310996https://www.arca.fiocruz.br/bitstream/icict/30576/2/Raltegravir%20with%20optimized%20background_Beatriz_Grinsztejn_INI_Lapclin-AIDS_2008.pdf35546e2ddcf142477ad8e40dea176237MD52TEXTRaltegravir with optimized 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| dc.title.pt_BR.fl_str_mv |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| title |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| spellingShingle |
Raltegravir with optimized background therapy for resistant HIV-1 infection Steigbigel, Roy T. HIV Raltegravir Drug Resistance Drug Therapy Antiretroviral effect |
| title_short |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| title_full |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| title_fullStr |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| title_full_unstemmed |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| title_sort |
Raltegravir with optimized background therapy for resistant HIV-1 infection |
| author |
Steigbigel, Roy T. |
| author_facet |
Steigbigel, Roy T. Cooper, David A. Kumar, Princy N. Eron, Joseph E. Schechter, Mauro Markowitz, Martin Loutfy, Mona R. Lennox, Jeffrey L. Gatell, Jose M. Rockstroh, Jurgen K. Katlama, Christine Yeni, Patrick Lazzarin, Adriano Clotet, Bonaventura Zhao, Jing Chen, Joshua Ryan, Desmond M. Rhodes, Rand R. Killar, John A. Gilde, Lucinda R. Strohmaier, Kim M. Meibohm, Anne R. Miller, Michael D. Hazuda, Daria J. Nessly, Michael L. DiNubile, Mark J. Isaacs, Robin D. Nguyen, Bach-Yen Teppler, Hedy |
| author_role |
author |
| author2 |
Cooper, David A. Kumar, Princy N. Eron, Joseph E. Schechter, Mauro Markowitz, Martin Loutfy, Mona R. Lennox, Jeffrey L. Gatell, Jose M. Rockstroh, Jurgen K. Katlama, Christine Yeni, Patrick Lazzarin, Adriano Clotet, Bonaventura Zhao, Jing Chen, Joshua Ryan, Desmond M. Rhodes, Rand R. Killar, John A. Gilde, Lucinda R. Strohmaier, Kim M. Meibohm, Anne R. Miller, Michael D. Hazuda, Daria J. Nessly, Michael L. DiNubile, Mark J. Isaacs, Robin D. Nguyen, Bach-Yen Teppler, Hedy |
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author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Steigbigel, Roy T. Cooper, David A. Kumar, Princy N. Eron, Joseph E. Schechter, Mauro Markowitz, Martin Loutfy, Mona R. Lennox, Jeffrey L. Gatell, Jose M. Rockstroh, Jurgen K. Katlama, Christine Yeni, Patrick Lazzarin, Adriano Clotet, Bonaventura Zhao, Jing Chen, Joshua Ryan, Desmond M. Rhodes, Rand R. Killar, John A. Gilde, Lucinda R. Strohmaier, Kim M. Meibohm, Anne R. Miller, Michael D. Hazuda, Daria J. Nessly, Michael L. DiNubile, Mark J. Isaacs, Robin D. Nguyen, Bach-Yen Teppler, Hedy |
| dc.subject.en.pt_BR.fl_str_mv |
HIV Raltegravir Drug Resistance Drug Therapy Antiretroviral effect |
| topic |
HIV Raltegravir Drug Resistance Drug Therapy Antiretroviral effect |
| description |
Presente no BENCHMRK Study Teams: Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. |
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2008 |
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2008 |
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2018-12-13T14:50:15Z |
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2018-12-13T14:50:15Z |
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STEIGBIGEL, Roy T. et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. New England Journal of Medicine, v. 359, n. 4, p. 339-354, 2008. |
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https://www.arca.fiocruz.br/handle/icict/30576 |
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0028-4793 |
| dc.identifier.doi.none.fl_str_mv |
10.1056/NEJMoa0708975 |
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STEIGBIGEL, Roy T. et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. New England Journal of Medicine, v. 359, n. 4, p. 339-354, 2008. 0028-4793 10.1056/NEJMoa0708975 |
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Massachusetts Medical Society |
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Massachusetts Medical Society |
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