Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)

Detalhes bibliográficos
Autor(a) principal: Nunes, Estevão P.
Data de Publicação: 2009
Outros Autores: Oliveira, Marilia Santini de, Merçon, Monica, Zajdenverg, Roberto, Faulhaber, José Claudio, Pilotto, José Henrique, Ribeiro, Jorge Eurico, Norton, Michael, Schechter, Mauro
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/39082
Resumo: Estevão P. Nunes. Instituto Nacional de Infectologia Evandro Chagas. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento.
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spelling Nunes, Estevão P.Oliveira, Marilia Santini deMerçon, MonicaZajdenverg, RobertoFaulhaber, José ClaudioPilotto, José HenriqueRibeiro, Jorge EuricoNorton, MichaelSchechter, Mauro2020-01-09T13:44:30Z2020-01-09T13:44:30Z2009NUNES, Estevão P. et al. Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clinical Trials, v. 10, n. 6, p. 368-374, 2009.1528-4336https://www.arca.fiocruz.br/handle/icict/3908210.1310/hct1006-3681945-5771Estevão P. Nunes. Instituto Nacional de Infectologia Evandro Chagas. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento.2021-01-09Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil.Hospital Geral de Nova Iguaçu. Setor de DST/AIDS. Nova Iguaçu, RJ, Brasil.Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil.Hospital Geral de Nova Iguaçu. Setor de DST/AIDS. Nova Iguaçu, RJ, Brasil.Hospital Geral de Nova Iguaçu. Setor de DST/AIDS. Nova Iguaçu, RJ, Brasil.Abbott Laboratories. Linden, NJ, USA.Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil.Long-term adverse events and expenses associated with HAART have led to an interest in simplifi ed therapy. Lopinavir/ritonavir monotherapy is attractive due to its potency and high genetic barrier. Methods: This is a 96-week, open-label, randomized study to assess the feasibility of using LPV/r monotherapy in patients with undetectable viral load after being on successful HAART for at least 6 months. Subjects were randomized (1:1) to either switch from HAART to LPV/r monotherapy or to maintain their previous regimen. Results: 60 patients were enrolled. Baseline characteristics were similar in both groups. At Week 96, by intention-to-treat analysis, 24/30 (80.0%) subjects in monotherapy group and 26/30 (86.6%) in the control group had a plasma viral load of <80 copies/mL. There was one virologic failure (defined as VL > 500 copies/mL) in each arm. Genotyping testing identifi ed no resistance-associated mutations. The patient on the monotherapy arm was successfully resuppressed to <80 copies/mL after intensifi cation with tenofovir and lamivudine. No statistically signifi cant differences were found with regard to changes in CD4 counts. One subject in the monotherapy group discontinued due to diarrhea. Five subjects in the control group underwent regimen changes due to drug-related toxicities. Viral load from semen samples collected at the end of follow-up was undetectable on 14/15 patients randomized to monotherapy. Conclusions: Switching from various HAART regimens to LPV/r monotherapy in patients who were virologically suppressed and without a history of previous virologic failure was effective, safe, and well tolerated through 96 weeks.engTaylor & FrancisMonotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHIVLopinavirRitonavirMaintenanceMonotherapyinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/39082/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51ORIGINALve_Nunes_Estevão_etal_INI_2009.pdfve_Nunes_Estevão_etal_INI_2009.pdfapplication/pdf177905https://www.arca.fiocruz.br/bitstream/icict/39082/2/ve_Nunes_Estev%c3%a3o_etal_INI_2009.pdfac985d01902f78628cd1e2b999e3fdc4MD52TEXTve_Nunes_Estevão_etal_INI_2009.pdf.txtve_Nunes_Estevão_etal_INI_2009.pdf.txtExtracted texttext/plain25969https://www.arca.fiocruz.br/bitstream/icict/39082/3/ve_Nunes_Estev%c3%a3o_etal_INI_2009.pdf.txt121859a171de464af0cb79f08911600aMD53icict/390822021-03-24 16:32:42.321oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352021-03-24T19:32:42Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
title Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
spellingShingle Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
Nunes, Estevão P.
HIV
Lopinavir
Ritonavir
Maintenance
Monotherapy
title_short Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
title_full Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
title_fullStr Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
title_full_unstemmed Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
title_sort Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo Study)
author Nunes, Estevão P.
author_facet Nunes, Estevão P.
Oliveira, Marilia Santini de
Merçon, Monica
Zajdenverg, Roberto
Faulhaber, José Claudio
Pilotto, José Henrique
Ribeiro, Jorge Eurico
Norton, Michael
Schechter, Mauro
author_role author
author2 Oliveira, Marilia Santini de
Merçon, Monica
Zajdenverg, Roberto
Faulhaber, José Claudio
Pilotto, José Henrique
Ribeiro, Jorge Eurico
Norton, Michael
Schechter, Mauro
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Nunes, Estevão P.
Oliveira, Marilia Santini de
Merçon, Monica
Zajdenverg, Roberto
Faulhaber, José Claudio
Pilotto, José Henrique
Ribeiro, Jorge Eurico
Norton, Michael
Schechter, Mauro
dc.subject.en.pt_BR.fl_str_mv HIV
Lopinavir
Ritonavir
Maintenance
Monotherapy
topic HIV
Lopinavir
Ritonavir
Maintenance
Monotherapy
description Estevão P. Nunes. Instituto Nacional de Infectologia Evandro Chagas. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento.
publishDate 2009
dc.date.issued.fl_str_mv 2009
dc.date.accessioned.fl_str_mv 2020-01-09T13:44:30Z
dc.date.available.fl_str_mv 2020-01-09T13:44:30Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv NUNES, Estevão P. et al. Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clinical Trials, v. 10, n. 6, p. 368-374, 2009.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/39082
dc.identifier.issn.pt_BR.fl_str_mv 1528-4336
dc.identifier.doi.none.fl_str_mv 10.1310/hct1006-368
dc.identifier.eissn.none.fl_str_mv 1945-5771
identifier_str_mv NUNES, Estevão P. et al. Monotherapy with lopinavir/ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clinical Trials, v. 10, n. 6, p. 368-374, 2009.
1528-4336
10.1310/hct1006-368
1945-5771
url https://www.arca.fiocruz.br/handle/icict/39082
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dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.publisher.none.fl_str_mv Taylor & Francis
publisher.none.fl_str_mv Taylor & Francis
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