Título : |
Randomized clinical trial of lovastatin in HIV-infected, HAART naïve patients (NCT00721305) |
Tipo de documento : |
documento electrónico |
Autores : |
Fabián Alberto Jaimes Barragán, ; Alba L. León, |
Fecha de publicación : |
2012 |
Títulos uniformes : |
Journal of Infection
|
Idioma : |
Inglés (eng) |
Palabras clave : |
HIV infection anti-HIV agents statin lovastatin randomized controlled trial |
Resumen : |
Background: Evidence suggests that statins may modify the immune response against HIV. The aim was to evaluate the antiretroviral and immunomodulatory effects of lov-astatin in HIV-infected patients, na€ıve for antiretroviral therapy. Methods: Randomized, double-blinded, placebo-controlled, phase-II clinical trial. Primary outcomes were plasma viral load and circulating CD4þ T cell count, after 6 and 12 months of treatment; secondary outcomes were CD8þ T cell count, expression of activation markers (CD38 and HLA-DR) on T cells, and clinical outcomes. With a power of 90% to detect both a decrease of 0.3 log10 in plasma HIV-1 RNA copies and an increase of 20% in the CD4þ T cell count, we estimated a required sample size of 110 HIV-infected patients (55 per group). The results were analyzed by a model of repeated measurements using Generalized Estimating Equations. Results: Patients were randomized to receive either lovastatin (n Z 55) or placebo (n Z 57). During the 12-month follow-up, there was no effect of lovastatin either on viral load (estimated average change Z 0.157 copies/mL; CI 95% Z 0.099 to 0.414), or on the CD4þ T cell count (estimated average change Z 26.1 cells/mL; CI 95% Z 89.8 to 37.6). Moreover, there were no significant differences in secondary outcomes. Conclusions: Daily administration of lovastatin (40 mg) for one year in HIV-infected patients, na€ıve for antiretroviral therapy, had no significant effect on HIV replication, the CD4þ T cell count, or the activation level of T cells. |
Mención de responsabilidad : |
Carlos J Montoya, Edwin A Higuita, Santiago Estrada, Francisco J Gutierrez, Pedro Amariles, Newar A Giraldo, Margarita M Jimenez, Claudia P Velasquez, Alba L Leon, Maria T Rugeles, Fabian A Jaimes |
Referencia : |
J Infect. 2012 Dec;65(6):549-58. |
DOI (Digital Object Identifier) : |
10.1016/j.jinf.2012.10.016 |
PMID : |
23085245 |
En línea : |
https://linkinghub.elsevier.com/retrieve/pii/S0163-4453(12)00302-7 |
Enlace permanente : |
https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=3602 |
Randomized clinical trial of lovastatin in HIV-infected, HAART naïve patients (NCT00721305) [documento electrónico] / Fabián Alberto Jaimes Barragán, ; Alba L. León, . - 2012. Obra : Journal of InfectionIdioma : Inglés ( eng) Palabras clave : |
HIV infection anti-HIV agents statin lovastatin randomized controlled trial |
Resumen : |
Background: Evidence suggests that statins may modify the immune response against HIV. The aim was to evaluate the antiretroviral and immunomodulatory effects of lov-astatin in HIV-infected patients, na€ıve for antiretroviral therapy. Methods: Randomized, double-blinded, placebo-controlled, phase-II clinical trial. Primary outcomes were plasma viral load and circulating CD4þ T cell count, after 6 and 12 months of treatment; secondary outcomes were CD8þ T cell count, expression of activation markers (CD38 and HLA-DR) on T cells, and clinical outcomes. With a power of 90% to detect both a decrease of 0.3 log10 in plasma HIV-1 RNA copies and an increase of 20% in the CD4þ T cell count, we estimated a required sample size of 110 HIV-infected patients (55 per group). The results were analyzed by a model of repeated measurements using Generalized Estimating Equations. Results: Patients were randomized to receive either lovastatin (n Z 55) or placebo (n Z 57). During the 12-month follow-up, there was no effect of lovastatin either on viral load (estimated average change Z 0.157 copies/mL; CI 95% Z 0.099 to 0.414), or on the CD4þ T cell count (estimated average change Z 26.1 cells/mL; CI 95% Z 89.8 to 37.6). Moreover, there were no significant differences in secondary outcomes. Conclusions: Daily administration of lovastatin (40 mg) for one year in HIV-infected patients, na€ıve for antiretroviral therapy, had no significant effect on HIV replication, the CD4þ T cell count, or the activation level of T cells. |
Mención de responsabilidad : |
Carlos J Montoya, Edwin A Higuita, Santiago Estrada, Francisco J Gutierrez, Pedro Amariles, Newar A Giraldo, Margarita M Jimenez, Claudia P Velasquez, Alba L Leon, Maria T Rugeles, Fabian A Jaimes |
Referencia : |
J Infect. 2012 Dec;65(6):549-58. |
DOI (Digital Object Identifier) : |
10.1016/j.jinf.2012.10.016 |
PMID : |
23085245 |
En línea : |
https://linkinghub.elsevier.com/retrieve/pii/S0163-4453(12)00302-7 |
Enlace permanente : |
https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=3602 |
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