Randomized clinical trial of lovastatin in HIV-infected, HAART naïve patients (NCT00721305)

Abstract

Evidence suggests that statins may modify the immune response against HIV. The aim was to evaluate the antiretroviral and immunomodulatory effects of lovastatin in HIV-infected patients, naïve for antiretroviral therapy. Randomized, double-blinded, placebo-controlled, phase-II clinical trial. Primary outcomes were plasma viral load and circulating CD4+ T cell count, after 6 and 12 months of treatment; secondary outcomes were CD8+ 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 0.3log10 in plasma HIV-1 RNA copies and an increase of 20% in the CD4+ 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. Patients were randomized to receive either lovastatin (n=55) or placebo (n=57). During the 12-month follow-up, there was no effect of lovastatin either on viral load (estimated average change=0.157copies/mL; CI 95%=-0.099 to 0.414), or on the CD4+ T cell count (estimated average change=-26.1cells/μL; CI 95%=-89.8 to 37.6). Moreover, there were no significant differences in secondary outcomes. Daily administration of lovastatin (40mg) for one year in HIV-infected patients, naïve for antiretroviral therapy, had no significant effect on HIV replication, the CD4+ T cell count, or the activation level of T cells. (www.clinicaltrials.gov; ID NCT00721305).