Author | Safe, Izabella Picinin | |
Author | Lacerda, Marcus Vinícius Guimarães | |
Author | Printes, Vitoria Silva | |
Author | Marins, Adriana Ferreira Praia | |
Author | Rabelo, Amanda Lia Rebelo | |
Author | Costa, Amanda Araújo | |
Author | Tavares, Michel Araújo | |
Author | Jesus, Jaquelane Silva | |
Author | Souza, Alexandra Brito | |
Author | Magalhães, Francisco Beraldi | |
Author | Neves, Cynthia Pessoa | |
Author | Monteiro, Wuelton Marcelo | |
Author | Sampaio, Vanderson Souza | |
Author | Amaral, Eduardo P. | |
Author | Gomes, Renata Spener | |
Author | Andrade, Bruno de Bezerril | |
Author | Santos, Marcelo Cordeiro | |
Access date | 2020-08-06T12:32:58Z | |
Available date | 2020-08-06T12:32:58Z | |
Document date | 2020 | |
Citation | SAFE, Izabella Picinin et al. Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study). Plos ONE, 2020. | pt_BR |
ISSN | 1932-6203 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/42572 | |
Sponsorship | Cooperação
Interfederativa do Amazonas (Interfam), funded by
the Brazilian Ministry of Health. MVGL,WMMand
BBA are CNPq fellows. | pt_BR |
Language | eng | pt_BR |
Publisher | Public Library of Science | pt_BR |
Rights | open access | pt_BR |
Subject in Portuguese | Tuberculose | pt_BR |
Subject in Portuguese | HIV | pt_BR |
Subject in Portuguese | Antimicrobianos | pt_BR |
Subject in Portuguese | Mortalidade | pt_BR |
Title | Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study) | pt_BR |
Type | Article | pt_BR |
Abstract | Despite the availability of effective antimicrobials, tuberculosis (TB) is still a serious health
threat. Mortality is even higher in people living with HIV who are diagnosed with TB. New
therapies are needed to shorten the time required to cure TB and decrease fatality rates in
this population. N-acetylcysteine (NAC) is a glutathione precursor and has shown recently
in experimental setting to present in vitro and in vivo anti-mycobacterial activity. We test the
hypothesis that NAC is safe, well tolerated and secondarily efficacious as adjunctive anti-TB
therapy in hospitalized individuals with HIV-associated TB. Patients were enrolled sequentially
in a tertiary care center, in the Brazilian Amazon. We performed a randomized, parallel
group, single-center, open study trial of two arms, in hospitalized patients over 18 years of
age, with microbiologically confirmed pulmonary TB in HIV: one with rifampicin, isoniazid,
pyrazinamide and ethambutol at standard doses (Control Group), and a second in which
NAC 600 mg bid for eight weeks was added (NAC Group). A total of 21 and 18 patients
were enrolled to the Control Group and NAC Group, respectively. Adverse event rates were
similar in the two arms. Our findings suggest that in the more critical population of hospitalized
patients with HIV-associated TB, the use of NAC was not unsafe, despite the low sample size, and a potential impact on faster negative cultures needs to be further explored
in larger studies. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil / Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade Federal do Amazonas. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | National Institutes of . Section, National Institutes of Allergy and Infectious Diseases. Bethesda, MD, United States of America. | pt_BR |
Affilliation | Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Inflamação e Biomarcadores. Salvador, BA, Brasil / Multinational Organization Network Sponsoring Translational and Epidemiological Research Initiative. Salvador, BA, Brasi / Universidade Salvador. Laureate Universities. Salvador, BA, Brasil / Faculdade de Tecnologia e Ciências. Curso de Medicina. Salvador, BA, Brasil / Escola Bahiana de Medicina e Saúde Pública. Salvador, BA, Brasil / University of Cape Town. Institute of Infectious Disease and Molecular Medicine. Wellcome Centre for Infectious Diseases Research in Africa. Cape Town, South Africa / Vanderbilt University School of Medicine. Division of Infectious Diseases. Department of Medicine. Nashville, TN, United States of America. | pt_BR |
Affilliation | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Programa de Pós-Graduação em Medicina Tropical. Manaus, AM, Brasil. | pt_BR |
Subject | Tuberculosis | pt_BR |
Subject | HIV | pt_BR |
Subject | Anti-Infective Agents | pt_BR |
Subject | Mortality | pt_BR |