title: Efficacy and safety of Buxus sempervirens L. preparations (SPV(30)) in HIV-infected asymptomatic patients: a multicentre, randomized, double-blind, placebo-controlled trial.
abstract: 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 < 200 × 10(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.
authors.affiliation: L'Archet Centre Hospitalier Universitaire de Nice, France.
authors.forename: J
authors.initials: J
authors.lastname: Durant
authors.forename: P
authors.initials: P
authors.lastname: Chantre
authors.forename: G
authors.initials: G
authors.lastname: Gonzalez
authors.forename: J
authors.initials: J
authors.lastname: Vandermander
authors.forename: P
authors.initials: P
authors.lastname: Halfon
authors.forename: B
authors.initials: B
authors.lastname: Rousse
authors.forename: D
authors.initials: D
authors.lastname: Guédon
authors.forename: V
authors.initials: V
authors.lastname: Rahelinirina
authors.forename: S
authors.initials: S
authors.lastname: Chamaret
authors.forename: L
authors.initials: L
authors.lastname: Montagnier
authors.forename: P
authors.initials: P
authors.lastname: Dellamonica