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Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration: Randomized crossover clinical trial in healthy volunteers

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dc.contributor.author Barroso, Sergio
dc.contributor.author Morén, Constanza
dc.contributor.author González Segura, Àlex
dc.contributor.author Riba, Neus
dc.contributor.author Arnaiz, Joan A.
dc.contributor.author Manriquez, Marcela
dc.contributor.author Santana, Gemina
dc.contributor.author Blanco, José L.
dc.contributor.author Larousse, María
dc.contributor.author Loncà, Montserrat
dc.contributor.author Lazzari, Elisa de
dc.contributor.author Llopis, Jaume
dc.contributor.author Mallolas, Josep
dc.contributor.author Miró, Òscar
dc.contributor.author Carné, Xavier
dc.contributor.author Gatell, Josep M.
dc.contributor.author Garrabou, Glòria
dc.contributor.author Martínez, Esteban
dc.date.accessioned 2020-07-16T08:01:40Z
dc.date.available 2020-07-16T08:01:40Z
dc.date.issued 2019
dc.identifier.citation Barroso S, Morén C, González-Segura À, Riba N, Arnaiz JA, Manriquez M, Santana G, Blanco JL, Larousse M, Loncà M, Lazzari E, Llopis J, Mallolas J, Miró O, Carné X, Gatell JM, Garrabou G, Martínez E. Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration: Randomized crossover clinical trial in healthy volunteers. PLoS One. 2019; 14(5):e0216712. DOI: 10.1371/journal.pone.0216712
dc.identifier.issn 1932-6203
dc.identifier.uri http://hdl.handle.net/10230/45124
dc.description.abstract Context: Classical antiretroviral agents may acutely impact on metabolic, mitochondrial, renal and hepatic function in HIV-infected and uninfected persons. Fusion and integrase inhibitors are supposed to be safer, but have been scarcely investigated. To avoid any interference with HIV or other antiretrovirals, we assessed markers of these toxicities in healthy adult volunteers treated with Enfuvirtide (T20) or Raltegravir (RAL). Methods: Twenty-six healthy participants were randomized to T20/90mg vs. placebo (n = 12) or RAL/400mg vs. placebo (n = 14) every 12h in two 7-day periods separated by a 4-week washout period. Major end-points were changes in lipid profile (total cholesterol, high-density-lipoprotein (HDL)-cholesterol, low-density-lipoprotein (LDL)-cholesterol, triglycerides), insulin resistance (glucose) and mitochondrial toxicity (mitochondrial DNA content-mtDNA-in peripheral blood mononuclear cells). Renal and hepatic toxicity (creatinine, alanine transaminase (AST), alanine aminotransferase (ALT), bilirubin and total plasma proteins) and overall safety were also analysed. Effect of period, treatment, and basal measures were evaluated for each end-point. Results: Neither T20-administration nor RAL-administration yielded to any statistic significant change in the markers of metabolic, mitochondrial, renal or hepatic toxicity assessed. No symptoms indicative of drug toxicity were neither found in any subject. Conclusions: In absence of HIV infection, or concomitant treatment, short-term exposure to T20 or RAL in healthy adult volunteers did not lead to any indicative changes in toxicity markers thus presuming the safe profile of both drugs.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Public Library of Science (PLoS)
dc.relation.ispartof PLoS One. 2019; 14(5):e0216712
dc.rights © 2019 Barroso et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.title Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration: Randomized crossover clinical trial in healthy volunteers
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0216712
dc.subject.keyword Toxicity
dc.subject.keyword Mitochondria
dc.subject.keyword Antiretrovirals
dc.subject.keyword Drug metabolism
dc.subject.keyword Mitochondrial DNA
dc.subject.keyword Antiretroviral therapy
dc.subject.keyword Cholesterol
dc.subject.keyword Insulin resistance
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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