Author | Cooper, David A | |
Author | Cordery, Damien V | |
Author | Zajdenverg, Roberto | |
Author | Ruxrungtham, Kiat | |
Author | Arastéh, Keikawus | |
Author | Bergmann, Frank | |
Author | Neto, José L de Andrade | |
Author | Scherer, Joseph | |
Author | Chaves, Ricardo L | |
Author | Robinson, Patrick | |
Author | Study Team | |
Access date | 2018-12-12T18:13:47Z | |
Available date | 2018-12-12T18:13:47Z | |
Document date | 2016 | |
Citation | 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. | pt_BR |
ISSN | 1932-6203 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/30539 | |
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). | pt_BR |
Language | eng | pt_BR |
Publisher | Public Library of Science | pt_BR |
Rights | open access | pt_BR |
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 | pt_BR |
Type | Article | pt_BR |
DOI | 10.1371/journal.pone.0144917 | |
Abstract | 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. | pt_BR |
Affilliation | University of New South Wales. The Kirby Institute. Sydney, Australia. | pt_BR |
Affilliation | University of New South Wales. The Kirby Institute. Sydney, Australia. | pt_BR |
Affilliation | GlaxoSmithKline. Assuntos Médicos, HIV, Doenças Infecciosas e Doenças Inflamatórias Imunitárias. Rio de Janeiro, RJ, Brasil. | pt_BR |
Affilliation | HIV-NAT. Thai Red Cross AIDS Research Centre./ Chulalongkorn University. Faculty of Medicine. Bangkok, Thailand. | pt_BR |
Affilliation | Vivantes Auguste-Viktoria Hospital. Epimed GmbH. Berlin, Germany. | pt_BR |
Affilliation | Humboldt University. Infectiology and Pulmonology. Department of Internal Medicine. Berlin, Germany. | pt_BR |
Affilliation | Instituto AZ de Pesquisa e Ensino. Curitiba, PR, Brasil. | pt_BR |
Affilliation | Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT, USA. | pt_BR |
Affilliation | Boehringer Ingelheim GmbH. Ingelheim, Germany. | pt_BR |
Affilliation | Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT, USA. | pt_BR |
Subject | HIV-1 | pt_BR |
Subject | Anti-HIV Agents | pt_BR |
Subject | CD4 Lymphocyte Count | pt_BR |
Subject | Drug Administration Schedule | pt_BR |
Subject | Lopinavir | pt_BR |
Subject | Ritonavir | pt_BR |
Subject | Tenofovir | pt_BR |