Oral Ganciclovir for the Prevention of Cytomegalovirus Disease in Persons with AIDS

Abstract

Background In the advanced stages of the acquired immunodeficiency syndrome (AIDS), cytomegalovirus (CMV) disease, particularly vision-damaging retinitis due to CMV, is common. We evaluated prophylactic treatment with orally administered ganciclovir as a way to prevent CMV disease. Methods We conducted a prospective, randomized, double-blind, placebo-controlled study of CMV-infected persons with AIDS with either CD4+ lymphocyte counts of <50 per cubic millimeter or counts of <100 per cubic millimeter in those with a history of an AIDS-defining opportunistic infection. Patients were randomly assigned, in a 2:1 ratio, to receive either oral ganciclovir (1000 mg three times daily) or placebo. Results The study was stopped after a median of 367 days of follow-up. In an intention-to-treat analysis, the 12-month cumulative rates of confirmed CMV disease were 26 percent in the placebo group (n = 239) and 14 percent in the ganciclovir group (n = 486), representing an overall reduction in risk of 49 percent in the...