Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2021 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| DOI: | 10.1097/MD9.0000000000000110 |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/48781 |
Resumo: | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. |
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Saraiva, Roberto MagalhãesPortela, Luciana FernandesSilveira, Gabriel Parreiras Estolano daGomes, Natalia Lins da SilvaPInto, Douglas PereiraSilva, Aline Campos de Azevedo daSangenis, Luiz Henrique CondeCarneiro, Fernanda MartinsSilva, Juliana AlmeidaMarinho, Patricia WinkSilva, Gilberto Marcelo SperandioEstrela, Rita de Cássia EliasHasslocher-Moreno, Alejandro MarcelMediano, Mauro Felippe FelixMoreira, Otacilio C.Brito, ConstançaChavez-Perez, Sandra AuroraViçosa, Alessandra LifsitchSuarez-Fontes, Ana MárciaVannier-Santos, Marcos André2021-08-27T17:22:49Z2021-08-27T17:22:49Z2021SARAIVA, Roberto Magalhães et al. Disulfiram repurposing in the combined chemotherapy of Chagas Disease. A protocol for phase I/II clinical trial. Medicine Case Reports and Study Protocols, v. 2, n. 7, p. 1-8, 2021.2589-8647https://www.arca.fiocruz.br/handle/icict/4878110.1097/MD9.00000000000001102589-8655engMedicine Case Reports and Study ProtocolDoença de ChagasQuimioterapiaDisulfiramReaproveitamento de drogasProtocoloEnsaio clínico de fase I / IIChagas diseaseChemotherapyDisulfiram repurposingProtocolPhase I/II clinical trialDisulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Vice-presidência de Produção e Inovação em Saúde. Serviço de Equivalência e Farmacocinética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Biologia Molecular e Doenças Endêmicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Vice-presidência de Produção e Inovação em Saúde. Serviço de Equivalência e Farmacocinética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Vice-presidência de Produção e Inovação em Saúde. Serviço de Equivalência e Farmacocinética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Escritório de Projetos. Escritório de Gerenciamento de Projetos em P&D. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Biologia Molecular e Doenças Endêmicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Biologia Molecular e Doenças Endêmicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Escritório de Projetos. Escritório de Gerenciamento de Projetos em P&D. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos. Laboratório de Farmacotécnica Experimental. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Background: Chagas disease (CD) has high morbimortality and the available trypanocidal treatment, including benznidazole (BZ), has limited efficacy in chronic patients. Furthermore, BZ causes adverse effects (AE) that prevent treatment completion in up to 30% of patients. The use of repositioned drugs or drug combination may provide an effective trypanocidal treatment. Disulfiram (DF) may enhance BZ activity and decrease BZ related AE. This study aims to assess the safety of a new combination of drugs for CD therapy, assuming BZ as the drug of choice plus DF as repositioned drug. Methods: This single-centre, open-label, phase I/II clinical trial was designed to evaluate the safety of the combined use of BZ plus DF for CD therapy. Participants are adults with indeterminate form of chronic CD, both sexes, aged from 18 to 70 years old and Trypanosoma cruzi polymerase chain reaction-positive. The primary outcome will be the occurrence of serious AE. The secondary outcome will be post-treatment Trypanosoma cruzi polymerase chain reaction negativization. Six groups of 9 patients will be sequentially tested. The first group will be allocated to receive BZ 100mg/d + DF 250mg/d for 60 days. Upon safety confirmation (<1/3 of participants with serious AE), the combination dose will be gradually increased and dispensed to 5 groups (group II:BZ 200mg/day+DF 250mg/d; group III:BZ 300mg/d + DF 250mg/d; group IV:BZ 100mg/d + DF 500mg/d; group V:BZ 200mg/d + DF 500mg/d; group VI: BZ 300mg/d + DF 500mg/d) for 60 days in order to determine the maximum tolerated dose. Discussion: Our hypothesis is that the drug combination will be well tolerated and allow the proposal of phase II trials in larger scale to test the efficacy of the new drug combination in CD. We expect that the studied combination will have less AEs with an efficacy.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/48781/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALAlineCSilva_JulianaAlmeida_etal_IOC_2021.pdfAlineCSilva_JulianaAlmeida_etal_IOC_2021.pdfapplication/pdf589589https://www.arca.fiocruz.br/bitstream/icict/48781/2/AlineCSilva_JulianaAlmeida_etal_IOC_2021.pdf3d29723ae22974c4690448f3faacaf6bMD52TEXTAlineCSilva_JulianaAlmeida_etal_IOC_2021.pdf.txtAlineCSilva_JulianaAlmeida_etal_IOC_2021.pdf.txtExtracted texttext/plain40915https://www.arca.fiocruz.br/bitstream/icict/48781/3/AlineCSilva_JulianaAlmeida_etal_IOC_2021.pdf.txta3512ea95f3e511beb6b1417f610d035MD53icict/487812022-06-24 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| dc.title.pt_BR.fl_str_mv |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| title |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| spellingShingle |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial Saraiva, Roberto Magalhães Doença de Chagas Quimioterapia Disulfiram Reaproveitamento de drogas Protocolo Ensaio clínico de fase I / II Chagas disease Chemotherapy Disulfiram repurposing Protocol Phase I/II clinical trial |
| title_short |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| title_full |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| title_fullStr |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| title_full_unstemmed |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| title_sort |
Disulfiram repurposing in the combined chemotherapy of Chagas disease A protocol for phase I/II clinical trial |
| author |
Saraiva, Roberto Magalhães |
| author_facet |
Saraiva, Roberto Magalhães Portela, Luciana Fernandes Silveira, Gabriel Parreiras Estolano da Gomes, Natalia Lins da Silva PInto, Douglas Pereira Silva, Aline Campos de Azevedo da Sangenis, Luiz Henrique Conde Carneiro, Fernanda Martins Silva, Juliana Almeida Marinho, Patricia Wink Silva, Gilberto Marcelo Sperandio Estrela, Rita de Cássia Elias Hasslocher-Moreno, Alejandro Marcel Mediano, Mauro Felippe Felix Moreira, Otacilio C. Brito, Constança Chavez-Perez, Sandra Aurora Viçosa, Alessandra Lifsitch Suarez-Fontes, Ana Márcia Vannier-Santos, Marcos André |
| author_role |
author |
| author2 |
Portela, Luciana Fernandes Silveira, Gabriel Parreiras Estolano da Gomes, Natalia Lins da Silva PInto, Douglas Pereira Silva, Aline Campos de Azevedo da Sangenis, Luiz Henrique Conde Carneiro, Fernanda Martins Silva, Juliana Almeida Marinho, Patricia Wink Silva, Gilberto Marcelo Sperandio Estrela, Rita de Cássia Elias Hasslocher-Moreno, Alejandro Marcel Mediano, Mauro Felippe Felix Moreira, Otacilio C. Brito, Constança Chavez-Perez, Sandra Aurora Viçosa, Alessandra Lifsitch Suarez-Fontes, Ana Márcia Vannier-Santos, Marcos André |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Saraiva, Roberto Magalhães Portela, Luciana Fernandes Silveira, Gabriel Parreiras Estolano da Gomes, Natalia Lins da Silva PInto, Douglas Pereira Silva, Aline Campos de Azevedo da Sangenis, Luiz Henrique Conde Carneiro, Fernanda Martins Silva, Juliana Almeida Marinho, Patricia Wink Silva, Gilberto Marcelo Sperandio Estrela, Rita de Cássia Elias Hasslocher-Moreno, Alejandro Marcel Mediano, Mauro Felippe Felix Moreira, Otacilio C. Brito, Constança Chavez-Perez, Sandra Aurora Viçosa, Alessandra Lifsitch Suarez-Fontes, Ana Márcia Vannier-Santos, Marcos André |
| dc.subject.other.pt_BR.fl_str_mv |
Doença de Chagas Quimioterapia Disulfiram Reaproveitamento de drogas Protocolo Ensaio clínico de fase I / II |
| topic |
Doença de Chagas Quimioterapia Disulfiram Reaproveitamento de drogas Protocolo Ensaio clínico de fase I / II Chagas disease Chemotherapy Disulfiram repurposing Protocol Phase I/II clinical trial |
| dc.subject.en.pt_BR.fl_str_mv |
Chagas disease Chemotherapy Disulfiram repurposing Protocol Phase I/II clinical trial |
| description |
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. |
| publishDate |
2021 |
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2021-08-27T17:22:49Z |
| dc.date.available.fl_str_mv |
2021-08-27T17:22:49Z |
| dc.date.issued.fl_str_mv |
2021 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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| dc.identifier.citation.fl_str_mv |
SARAIVA, Roberto Magalhães et al. Disulfiram repurposing in the combined chemotherapy of Chagas Disease. A protocol for phase I/II clinical trial. Medicine Case Reports and Study Protocols, v. 2, n. 7, p. 1-8, 2021. |
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https://www.arca.fiocruz.br/handle/icict/48781 |
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2589-8647 |
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10.1097/MD9.0000000000000110 |
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2589-8655 |
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SARAIVA, Roberto Magalhães et al. Disulfiram repurposing in the combined chemotherapy of Chagas Disease. A protocol for phase I/II clinical trial. Medicine Case Reports and Study Protocols, v. 2, n. 7, p. 1-8, 2021. 2589-8647 10.1097/MD9.0000000000000110 2589-8655 |
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https://www.arca.fiocruz.br/handle/icict/48781 |
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Medicine Case Reports and Study Protocol |
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