Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial

Detalhes bibliográficos
Autor(a) principal: Cooper, David A
Data de Publicação: 2016
Outros Autores: Cordery, Damien V, Zajdenverg, Roberto, Ruxrungtham, Kiat, Arastéh, Keikawus, Bergmann, Frank, Neto, José L de Andrade, Scherer, Joseph, Chaves, Ricardo L, Robinson, Patrick, Study Team
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/30539
Resumo: Presentes no Study Team: Beatriz Grinsztejn; Marília Santini (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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spelling Cooper, David ACordery, Damien VZajdenverg, RobertoRuxrungtham, KiatArastéh, KeikawusBergmann, FrankNeto, José L de AndradeScherer, JosephChaves, Ricardo LRobinson, PatrickStudy Team2018-12-12T18:13:47Z2018-12-12T18:13:47Z2016COOPER, D. A. et al. Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial. PloS one, v. 11, n. 1, p. e0144917, 2016.1932-6203https://www.arca.fiocruz.br/handle/icict/3053910.1371/journal.pone.0144917Presentes no Study Team: Beatriz Grinsztejn; Marília Santini (Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil).University of New South Wales. The Kirby Institute. Sydney, Australia.University of New South Wales. The Kirby Institute. Sydney, Australia.GlaxoSmithKline. Assuntos Médicos, HIV, Doenças Infecciosas e Doenças Inflamatórias Imunitárias. Rio de Janeiro, RJ, Brasil.HIV-NAT. Thai Red Cross AIDS Research Centre./ Chulalongkorn University. Faculty of Medicine. Bangkok, Thailand.Vivantes Auguste-Viktoria Hospital. Epimed GmbH. Berlin, Germany.Humboldt University. Infectiology and Pulmonology. Department of Internal Medicine. Berlin, Germany.Instituto AZ de Pesquisa e Ensino. Curitiba, PR, Brasil.Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT, USA.Boehringer Ingelheim GmbH. Ingelheim, Germany.Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT, USA.Ritonavir-boosted tipranavir (TPV/r) was evaluated as initial therapy in treatment-naïve HIV-1-infected patients because of its potency, unique resistance profile, and high genetic barrier. Trial 1182.33, an open-label, randomized trial, compared two TPV/r dose combinations versus ritonavir-boosted lopinavir (LPV/r). Eligible adults, who had no prior antiretroviral therapy were randomized to twice daily (BID) 500/100 mg TPV/r, 500/200 mg TPV/r, or 400/100 mg LPV/r. Each treatment group also received Tenofovir 300 mg + Lamivudine 300 mg QD. The primary endpoint was a confirmed viral load (VL) <50 copies/mL at week 48 without prior antiretroviral regimen changes. Primary analyses examined CD4-adjusted response rates for non-inferiority, using a 15% non-inferiority margin. At week 48, VL<50 copies/mL was 68.4%, 69.9%, and 72.4% in TPV/r100, TPV/r200, and LPV/r groups, respectively, and TPV/r groups showed non-inferiority to LPV/r. Discontinuation due to adverse events was higher in TPV/r100 (10.3%) and TPV/r200 (15.3%) recipients versus LPV/r (3.2%) recipients. The frequency of grade ≥3 transaminase elevations was higher in the TPV/r200 group than the other groups, leading to closure of this group. However, upon continued treatment or following re-introduction after treatment interruption, transaminase elevations returned to grade ≤2 in >65% of patients receiving either TPV/r200 or TPV/r100. The trial was subsequently discontinued; primary objectives were achieved and continuing TPV/r100 was less tolerable than standard of care for initial highly active antiretroviral therapy. All treatment groups had similar 48-week treatment responses. TPV/r100 and TPV/r200 regimens resulted in sustained treatment responses, which were non-inferior to LPV/r at 48 weeks. When compared with the LPV/r regimen and examined in the light of more current regimens, these TPV/r regimens do not appear to be the best options for treatment-naïve patients based on their safety profiles.engPublic Library of ScienceTipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHIV-1Anti-HIV AgentsCD4 Lymphocyte CountDrug Administration ScheduleLopinavirRitonavirTenofovirinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
title Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
spellingShingle Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
Cooper, David A
HIV-1
Anti-HIV Agents
CD4 Lymphocyte Count
Drug Administration Schedule
Lopinavir
Ritonavir
Tenofovir
title_short Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
title_full Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
title_fullStr Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
title_full_unstemmed Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
title_sort Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
author Cooper, David A
author_facet Cooper, David A
Cordery, Damien V
Zajdenverg, Roberto
Ruxrungtham, Kiat
Arastéh, Keikawus
Bergmann, Frank
Neto, José L de Andrade
Scherer, Joseph
Chaves, Ricardo L
Robinson, Patrick
Study Team
author_role author
author2 Cordery, Damien V
Zajdenverg, Roberto
Ruxrungtham, Kiat
Arastéh, Keikawus
Bergmann, Frank
Neto, José L de Andrade
Scherer, Joseph
Chaves, Ricardo L
Robinson, Patrick
Study Team
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Cooper, David A
Cordery, Damien V
Zajdenverg, Roberto
Ruxrungtham, Kiat
Arastéh, Keikawus
Bergmann, Frank
Neto, José L de Andrade
Scherer, Joseph
Chaves, Ricardo L
Robinson, Patrick
Study Team
dc.subject.en.pt_BR.fl_str_mv HIV-1
Anti-HIV Agents
CD4 Lymphocyte Count
Drug Administration Schedule
Lopinavir
Ritonavir
Tenofovir
topic HIV-1
Anti-HIV Agents
CD4 Lymphocyte Count
Drug Administration Schedule
Lopinavir
Ritonavir
Tenofovir
description Presentes no Study Team: Beatriz Grinsztejn; Marília Santini (Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil).
publishDate 2016
dc.date.issued.fl_str_mv 2016
dc.date.accessioned.fl_str_mv 2018-12-12T18:13:47Z
dc.date.available.fl_str_mv 2018-12-12T18:13:47Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv COOPER, D. A. et al. Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial. PloS one, v. 11, n. 1, p. e0144917, 2016.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/30539
dc.identifier.issn.pt_BR.fl_str_mv 1932-6203
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pone.0144917
identifier_str_mv COOPER, D. A. et al. Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial. PloS one, v. 11, n. 1, p. e0144917, 2016.
1932-6203
10.1371/journal.pone.0144917
url https://www.arca.fiocruz.br/handle/icict/30539
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
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collection Repositório Institucional da FIOCRUZ (ARCA)
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