Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/40473 |
Resumo: | University of Miami Miller School of Medicine. Miami, FL, USA. |
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Boulanger, CatherineRolla, ValeriaAl-Shaer, Mohammad H.Peloquin, Charles2020-03-24T14:12:02Z2020-03-24T14:12:02Z2020BOULANGER, Catherine et al. Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis. International Journal of Antimicrobial Agents, v. 55, n. 2, p. 1-19, 2020.0924-8579https://www.arca.fiocruz.br/handle/icict/4047310.1016/j.ijantimicag.2019.10.021engElsevierHIVLopinavirPharmacokineticsRifampicinRitonavirTuberculosisEvaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversity of Miami Miller School of Medicine. Miami, FL, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.University of Florida. College of Pharmacy, and Emerging Pathogens Institute. Gainesville, FL, USA.University of Florida. College of Pharmacy, and Emerging Pathogens Institute. Gainesville, FL, USA.Rifampicin induces the metabolism of many drugs. To overcome the reduction in serum concentrations of lopinavir/ritonavir (LPV/r) when used in combination with rifampicin, 800/200 mg or 400/400 mg doses are used. This study evaluated super-boosted LPV/r (400/400 mg) in HIV/TB co-infected patients for adequate concentrations as well as short-term safety, tolerability and clinical response to therapy. This was an open-label, non-randomised pharmacokinetic (PK) study in HIV/TB patients. The primary objective was to determine the PK profile of super-boosted LPV/r when given with a rifampicin-based TB regimen. Secondary objectives were short-term safety, tolerability and clinical response. Primary endpoints were a lopinavir trough concentration (Cmin) >1.0 µg/mL and a rifampicin maximum concentration (Cmax) of 8-24 µg/mL. Secondary PK endpoints were a rifampicin area under the concentration-time curve from 0-24 h (AUC0-24) of 44-70 µg·h/mL, a lopinavir Cmax of 6-14 µg/mL and a lopinavir AUC0-12 of 56-130 µg·h/mL. Eleven patients (10 male, age 25-43 years) were enrolled. Two patients were discontinued due to non-compliance. A lopinavir Cmin of >1.0 µg/mL was achieved in a least one of the PK samplings in all nine subjects who completed treatment. All patients met lopinavir Cmax and AUC0-12 targets. Five patients achieved the primary endpoint of rifampicin Cmax (≥8 µg/mL) in at least one of the PK samplings, and five achieved the minimum rifampicin AUC0-24 (≥44 µg·h/mL). One grade 3 adverse event was reported. Super-boosted LPV/r was safe and effective in HIV/TB patients. [ClinicalTrials.gov ID NCT01700790.].info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/40473/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALEvaluation of Super-Boosted_Valeria_Rolla_etal_INI_2020.pdfEvaluation of Super-Boosted_Valeria_Rolla_etal_INI_2020.pdfapplication/pdf718931https://www.arca.fiocruz.br/bitstream/icict/40473/2/Evaluation%20of%20Super-Boosted_Valeria_Rolla_etal_INI_2020.pdf6271610dfb46524a28f3718ebe714d7fMD52TEXTEvaluation of Super-Boosted_Valeria_Rolla_etal_INI_2020.pdf.txtEvaluation of Super-Boosted_Valeria_Rolla_etal_INI_2020.pdf.txtExtracted texttext/plain21474https://www.arca.fiocruz.br/bitstream/icict/40473/3/Evaluation%20of%20Super-Boosted_Valeria_Rolla_etal_INI_2020.pdf.txt7f7a687cb9f3dd6ad2522c36c028b165MD53icict/404732020-03-25 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dc.title.pt_BR.fl_str_mv |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
title |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
spellingShingle |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis Boulanger, Catherine HIV Lopinavir Pharmacokinetics Rifampicin Ritonavir Tuberculosis |
title_short |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
title_full |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
title_fullStr |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
title_full_unstemmed |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
title_sort |
Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis |
author |
Boulanger, Catherine |
author_facet |
Boulanger, Catherine Rolla, Valeria Al-Shaer, Mohammad H. Peloquin, Charles |
author_role |
author |
author2 |
Rolla, Valeria Al-Shaer, Mohammad H. Peloquin, Charles |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Boulanger, Catherine Rolla, Valeria Al-Shaer, Mohammad H. Peloquin, Charles |
dc.subject.other.pt_BR.fl_str_mv |
HIV Lopinavir Pharmacokinetics Rifampicin Ritonavir Tuberculosis |
topic |
HIV Lopinavir Pharmacokinetics Rifampicin Ritonavir Tuberculosis |
description |
University of Miami Miller School of Medicine. Miami, FL, USA. |
publishDate |
2020 |
dc.date.accessioned.fl_str_mv |
2020-03-24T14:12:02Z |
dc.date.available.fl_str_mv |
2020-03-24T14:12:02Z |
dc.date.issued.fl_str_mv |
2020 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
BOULANGER, Catherine et al. Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis. International Journal of Antimicrobial Agents, v. 55, n. 2, p. 1-19, 2020. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/40473 |
dc.identifier.issn.pt_BR.fl_str_mv |
0924-8579 |
dc.identifier.doi.pt_BR.fl_str_mv |
10.1016/j.ijantimicag.2019.10.021 |
identifier_str_mv |
BOULANGER, Catherine et al. Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis. International Journal of Antimicrobial Agents, v. 55, n. 2, p. 1-19, 2020. 0924-8579 10.1016/j.ijantimicag.2019.10.021 |
url |
https://www.arca.fiocruz.br/handle/icict/40473 |
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eng |
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eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
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Elsevier |
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Elsevier |
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