Efficacy and safety of Buxus sempervirens L. preparations (SPV30) in HIV-infected asymptomatic patients: a multicentre, randomized, double-blind, placebo-controlled trial

Summary The objective of the present study was to compare the efficacy and safety of two doses of SPV 30 in HIV asymptomatic patients. The study was designed as a randomized double-blind multicentre trial of two doses of SPV 30 (990 mg/d and 1980 mg/d) versus placebo. 145 previously untreated subjects with asymptomatic HIV infection (CDC group IV) and CD4 cell counts between 250 and 500 × 10 6 /1 were recruited. There was a statistically significant difference in therapeutic failures between groups in favor of SPV 30 990 mg including decreases of CD4 cell count 6 /1 and/or number of clinical aggravations (progression to AIDS or AIDS related complex). The treatment groups differed statistically in the rate of disease progression also in favor of SPV 30 990 mg/d. Fewer patients receiving SPV 30 990 mg/d had at the end an increase of viral load greater than 0.5 log ( P = 0.029). No severe side-effects were reported in the 3 groups. From these results we conclude that SPV 30 990 mg/d has beneficial effects in HIV asymptomatic patients and appears to delay the progression of HIV disease.