Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/9969
Title: Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Refl ate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial
Authors: Grinsztejn, Beatriz
Veloso, Valdiléa G.
Vorsatz, Carla
Santini-Oliveira, Marilia
Castro, Nathalie de
Molina, Jean- Michel
Delaugerre, Constance
Arnold, Vincent
Fagard, Catherine
Ghêne, Geneviève
Morgado, Mariza
Pilotto, José Henrique
Brittes, Carlos
Madruga, José Valdez
Barcellos, Nêmora Tregnago
Santos, Breno Riegel
Patey, Olivier
Affilliation: Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas (IPEC). Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas (IPEC). Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas (IPEC). Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas (IPEC). Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Sorbonne Paris Cité. Department of Infectious Diseases. Paris, França.
Sorbonne Paris Cité. Department of Infectious Diseases. Paris, França / Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, France.
University of Bordeaux. ISPED. Epidemiologie- Biostatistique, Bordeaux, France.
University of Bordeaux. ISPED. Epidemiologie- Biostatistique, Bordeaux, France.
University of Bordeaux. ISPED. Epidemiologie- Biostatistique, Bordeaux, France.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Departamento de DST/AIDS. Nova Iguaçu, RJ, Brasil.
Hospital Universitário Prof Edgar Santos. Laboratório de Pesquisa em Doenças Infecciosas. Bahia, Brasil.
Centro de Referência e Treinamento DST/AIDS. São Paulo, Brasil
Health State Secretariat/RS. Hospital Sanatório Partenon. Rio Grande do Sul, Brasil.
Hospital Nossa Senhora da Conceição. Serviço de Infectologia. Porto Alegre, RS, Brasil.
Department of IDepartment of Internal and Tropical Medicine, Villeneuve St George, France.
CHU de Bordeaux, Pôle de Santé Publique. Service d’information médicale. Bordeaux, France.
Abstract: Background Concurrent treatment of HIV and tuberculosis is complicated by drug interactions. We explored the safety and effi cacy of raltegravir as an alternative to efavirenz for patients co-infected with HIV and tuberculosis. Methods We did a multicentre, phase 2, non-comparative, open-label, randomised trial at eight sites in Brazil and France. Using a computer-generated randomisation sequence, we randomly allocated antiretroviral-naive adult patients with HIV-1 and tuberculosis (aged ≥18 years with a plasma HIV RNA concentration of >1000 copies per mL) to receive raltegravir 400 mg twice a day, raltegravir 800 mg twice daily, or efavirenz 600 mg once daily plus tenofovir and lamivudine (1:1:1; stratifi ed by country). Patients began study treatment after the start of tuberculosis treatment. The primary endpoint was virological suppression at 24 weeks (HIV RNA <50 copies per mL) in all patients who received at least one dose of study drug (modifi ed intention-to-treat analysis). We recorded death, study drug discontinuation, and loss to follow-up as failures to achieve the primary endpoint. We assessed safety in all patients who received study drugs. This study is registered in ClinicalTrials.gov, number NCT00822315. Findings Between July 3, 2009, and June 6, 2011, we enrolled and randomly assigned treatment to 155 individuals; 153 (51 in each group) received at least one dose of the study drug and were included in the primary analysis. 133 patients (87%) completed follow-up at week 48. At week 24, virological suppression was achieved in 39 patients (76%, 95% CI 65–88) in the raltegravir 400 mg group, 40 patients (78%, 67–90) in the raltegravir 800 mg group, and 32 patients (63%, 49–76) in the efavirenz group. The adverse-event profi le was much the same across the three groups. Three (6%) patients allocated to efavirenz and three (6%) patients allocated to raltegravir 800 mg twice daily discontinued the study drugs due to adverse events. Seven patients died during the study (one in the raltegravir 400 mg group, four in the raltegravir 800 mg group, and two in the efavirenz group): none of the deaths was deemed related to study treatment. Interpretation Raltegravir 400 mg twice daily might be an alternative to efavirenz for the treatment of patients co-infected with HIV and tuberculosis.
Keywords: HIV
Tuberculosis
Raltegravir
Randomised trial
Issue Date: 2014
Publisher: The Lancet
Citation: Grinsztein, B. et al. Lancet Infectious Diseases, n. 14, p. 459-467, 2014
DOI: 10.1016/ S1473-3099(14)70711-X
Copyright: restricted access
Appears in Collections:INI - Artigos de Periódicos
IOC - Artigos de Periódicos

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