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dc.contributor.authorMadruga, José Valdez
dc.contributor.authorCahn, Pedro
dc.contributor.authorGrinsztejn, Beatriz
dc.contributor.authorHaubrich, Richard
dc.contributor.authorLalezari, Jacob
dc.contributor.authorMills, Anthony
dc.contributor.authorPialoux, Gilles
dc.contributor.authorWilkin, Timothy
dc.contributor.authorPeeters, Monika
dc.contributor.authorVingerhoets, Johan
dc.contributor.authorde Smedt, Goedele
dc.contributor.authorLeopold, Lorant
dc.contributor.authorTrefiglio, Roberta
dc.contributor.authorWoodfall, Brian
dc.contributor.authorDUET-1 study group
dc.date.accessioned2019-01-17T22:10:26Z
dc.date.available2019-01-17T22:10:26Z
dc.date.issued2007
dc.identifier.citationMADRUGA, José Valdez et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. The Lancet, v. 370, p. 29–38, 2007.
dc.identifier.issn0140-6736
dc.identifier.urihttps://www.arca.fiocruz.br/handle/icict/31128
dc.language.isoeng
dc.publisherElsevier
dc.rightsrestricted access
dc.titleEfficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial
dc.typeArticle
dc.identifier.doi10.1016/S0140-6736(07)61047-2
dc.description.abstractenBackground: Antiretroviral agents active against drug-resistant HIV-1 are needed for treatment-experienced patients. The aim of this trial was to assess the effi cacy, safety, and tolerability of TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Methods: DUET-1 is a continuing, multinational randomised, double-blind, placebo-controlled, phase III trial. Treatment-experienced adult patients with virological failure on stable antiretroviral therapy, documented genotypic evidence of NNRTI resistance, viral load over 5000 copies per mL, and three or more primary protease inhibitor mutations were randomly assigned to receive 200 mg TMC125 or placebo twice daily. All patients also received darunavir with low-dose ritonavir and investigator-selected nucleoside reverse transcriptase inhibitors. Enfuvirtide use was optional. The primary endpoint was a confi rmed viral load below 50 copies per mL at week 24 (FDA time-toloss of virological response algorithm). Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00254046. Findings: 612 patients were randomised and treated (304 in the TMC125 group, 308 in the placebo group). By week 24, 42 (14%) patients in the TMC125 group and 56 (18%) in the placebo group had discontinued, mainly due to virological failure. At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0·005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhoea (36 [12%] patients on TMC125 vs 63 [20%] on placebo). Interpretation: In treatment-experienced patients with NNRTI resistance, treatment with TMC125 achieved better virological suppression at week 24 than did placebo. The safety and tolerability profi le of TMC125 was generally comparable with placebo.
dc.creator.affilliationCentro de Referência e Treinamento DST/AIDS. São Paulo, SP, Brasil.
dc.creator.affilliationHospital Juan A. Fernández and Fundación Huesped. Buenos Aires, Argentina.
dc.creator.affilliationFundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Rio de Janeiro, RJ, Brasil.
dc.creator.affilliationUniversity of California San Diego. San Diego, CA, USA.
dc.creator.affilliationQuest Clinical Research. San Francisco, CA, USA.
dc.creator.affilliationPrivate Practice. Los Angeles, CA, USA.
dc.creator.affilliationService des Maladies Infectieuses. Paris, France.
dc.creator.affilliationWeill Medical College of Cornell University. New York, NY, USA.
dc.creator.affilliationTibotec BVBA. Mechelen, Belgium.
dc.creator.affilliationTibotec BVBA. Mechelen, Belgium.
dc.creator.affilliationTibotec BVBA. Mechelen, Belgium.
dc.creator.affilliationTibotec In. Yardley, PA, USA.
dc.creator.affilliationTibotec In. Yardley, PA, USA.
dc.creator.affilliationTibotec BVBA. Mechelen, Belgium.
dc.subject.enHIV-1
dc.subject.enEtravirine
dc.subject.enHIV-1-infected patients in DUET-1
Appears in Collections:INI - Artigos de Periódicos

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