A RANDOMIZED, DOUBLE-BLIND TRIAL OF VALACICLOVIR PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE IN PATIENTS WITH ADVANCED HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

Cytomegalovirus (CMV) disease is a common complication of advanced hum an immunodeficiency virus (HIV) infection, Administration of oral vala ciclovir, a valine ester of acyclovir, achieves sufficient plasma acyc lovir levels to inhibit many clinical isolates, Acyclovir has been ass ociated with enhanced survival in AIDS but not with CMV disease preven tion, CMV-seropositive patients (1227) with CD4 cell counts <100/mm(3) were enrolled in a randomized, double-blind trial, Valaciclovir, 8 g/ day, was compared with acyclovir, 3.2 or 0.8 g/day, for CMV prevention ; all three arms were compared for survival, The confirmed CMV disease rate was 11.7% among valaciclovir recipients and 17.5% in the pooled acyclovir arms, a 33% reduction in risk, Time to confirmed CMV disease was significantly longer for the valaciclovir group (P = .03), A tren d toward earlier mortality for valaciclovir recipients was seen (P = . 06), Toxicity and earlier medication discontinuation were more common in this group, Valaciclovir significantly reduces the risk of CMV dise ase, Further exploration of a better-tolerated dose is warranted.