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| Pàgina inicial > Articles > Articles publicats > Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration : |
(Universitat Autònoma de Barcelona) (Universitat de Barcelona) (Universitat de Barcelona) (Hospital Clínic i Provincial de Barcelona) (Hospital Clínic i Provincial de Barcelona) (Hospital Clínic i Provincial de Barcelona)
| Data: | 2019 |
| Resum: | 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. |
| Ajuts: | Instituto de Salud Carlos III FIS-01199-11 Instituto de Salud Carlos III FIS-00462-11 Instituto de Salud Carlos III FIS-01199-12 Instituto de Salud Carlos III FIS-01738-13 Instituto de Salud Carlos III FIS-01455-13 Instituto de Salud Carlos III PI00005-14 Instituto de Salud Carlos III PI00817-15 Instituto de Salud Carlos III PI00903-15 Instituto de Salud Carlos III PI00130-15 Instituto de Salud Carlos III PIE1400061 Agència de Gestió d'Ajuts Universitaris i de Recerca 2014/SGR-376 Agència de Gestió d'Ajuts Universitaris i de Recerca 2014/SGR-928 |
| Nota: | Altres ajuts: This work was supported by: Fundación para la Investigación y la Prevención del SIDA en España [FIPSE 360982/10]. La Marató de TV3 [87/C/2015]; Fundació Cellex; and "la Caixa" Foundation. |
| Drets: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.  |
| Llengua: | Anglès |
| Document: | Article ; recerca ; Versió publicada |
| Matèria: | Adult ; Alanine Transaminase ; Anti-Retroviral Agents ; Creatine ; Enfuvirtide ; Healthy Volunteers ; HIV Infections ; Humans ; Insulin Resistance ; Kidney ; Leukocytes, Mononuclear ; Lipids ; Liver ; Male ; Metabolism ; Mitochondria ; Raltegravir Potassium |
| Publicat a: | PloS one, Vol. 14 Núm. 5 (may 2019) , p. e0216712, ISSN 1932-6203 |
