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

Summary Background 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, naive for antiretroviral therapy. Methods 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 0.3 log10 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 . Results 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 = 0.157 copies/mL; CI 95% = −0.099 to 0.414), or on the CD4+ T cell count (estimated average change = −26.1 cells/μL; CI 95% = −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, naive 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).