A RANDOMIZED, CONTROLLED-STUDY OF INTRAVENOUS GANCICLOVIR THERAPY FORCYTOMEGALOVIRUS PERIPHERAL RETINITIS IN PATIENTS WITH AIDS

This prospective, randomized, multicenter, controlled trial was design ed to evaluate the efficacy and safety of intravenous ganciclovir for the treatment of peripheral cytomegalovirus (CMV) retinitis in patient s with AIDS. Patients were randomly assigned to receive either immedia te treatment, intravenous ganciclovir, 5 mg/kg twice daily for 14 days followed by 5 mg/kg once daily for 14 weeks, or deferred treatment. P atients randomized to deferred treatment whose retinitis progressed we re offered ganciclovir. Of the 22 patients randomized to deferred trea tment who were included in the final analysis, 20 were found to have p rogressive CMV retinitis compared with 10 of the 13 randomized to imme diate treatment. The median time to progression in the deferred treatm ent group, as determined by a masked fundus photography reading center , was 13.5 days compared with 49.5 days in the immediate treatment gro up (mean +/- SD, 19.3 +/- 4.1 vs. 66.4 +/- 14.0; P = .001, log rank te st). These data indicate that ganciclovir delays the progression of CM V peripheral retinitis in persons with AIDS.