Katia Falasca, Claudio Ucciferri, Marta Di Nicola, Francesca Vignale, Delia Racciatti and Jacopo Vecchiet
Background: Despite the recent advances in antiretroviral therapy, human immunodeficiency virus type 1 (HIV-1) remains a global health threat. The aim of this study was evaluated the efficacy of a four-drug induction antiretroviral therapy (ART), including raltegravir (RAL), on the rapidity of suppression of plasma HIV-RNA below detectable concentrations and its impact on immunological recovery. Methods: In this single centre, randomized prospective trial, 32 naïve HIV+ patients at the same clinical stage were enrolled and randomized for baseline viral load: sixteen subjects started ART with four antiretroviral drugs including RAL, while the remaining patients started the same therapy without RAL. Viro-immunological and metabolic parameters, indexes of hepatic and renal functionality were measured at baseline (T0) and after three (T3), six (T6) and twelve months (T12) from therapy introduction. Results: We observed a faster viral drop in the group under RAL-therapy with respect to the other group. At the first month (T1) of therapy, the HIV-RNA was significantly lower in the patients receiving RAL-therapy (p<0.05). Immunological recovery was higher in patients with RAL than in those on other therapy at all detection times, with a significant increase at T3, T6 and T12 (p=0.02). Conclusion: In this study, we found, for the first time, a rapid and significant improvement in CD4+ T cells count in patients with four drug induction therapies. The four-drug regimen was safe, well tolerated and also associated with a rapid decay of plasma HIV-RNA levels.
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