Purpose. People living with HIV have higher rates of malignancies than the general population in the era of active antiretroviral therapy (ART). Genotoxic effects of HIV infection and/or ART that can induce neoplastic development are not yet well known. A prospective cohort study to investigate DNA damage measured through the micronuclei (MN) frequency in HIV-patients has been performed. Methods. Peripheral blood mononuclear cells (PBMC) were isolated from 52 HIV-patients treated with ART and 55 healthy controls. Results. By the comparison of MN frequency, a significant difference between HIV-patients (15.5 ± 9.8) and controls (6.0 ± 3.6) (p < 0.001) has been revealed. In univariate linear regression analysis, HCV infection (r = 0.31; p < 0.001), HIV-RNA (r = 0.29; p < 0.03) and duration of infection (r = - 0.16; p < 0.25) were associated with MN frequency; while only viral load (VL) significantly correlates (r = 0.29; p < 0.05) in a multiple regression model. Conclusions. The association of VL with MN frequency supports a genotoxic effect of HIV infection
