Objectives: To compare the safety and efficacy of oral ganciclovir with intravenous ganciclovir for the maintenance therapy of cytomegalovirus (CMV) retinitis in AIDS patients. Design: Multicenter, randomized, open-label study, with both masked and unmasked ophthalmic assessments. Methods: Patients with AIDS and stable CMV retinitis were randomized after an induction course of intravenous ganciclovir (5 mg/kg twice daily) to receive maintenance therapy with oral ganciclovir (500 mg six times daily) or intravenous ganciclovir (5 mg/kg once daily). Main outcome measure: The primary endpoint of the study was time to progression of CMV retinitis from the start of maintenance therapy. Results: The mean time to progression, evaluated by funduscopy was 109 days for the intravenous group, and 86 days for the oral group (P= 0.02). The masked photographic assessment revealed shorter time to progression for both oral and intravenous groups, as compared with funduscopy data, and showed no significant difference between the two treatment groups: 62 days for intravenous ganciclovir and 51 days for oral ganciclovir (P = 0.15). Diarrhea and neutropenia were the most frequent reported events in both groups, with the incidence of sepsis more than double in the intravenous compared with the oral ganciclovir group (3 versus 8.5%). Conclusions: Oral ganciclovir offers a reasonable alternative to intravenous ganciclovir for the maintenance therapy of CMV retinitis in AIDS patients.
|Publication status||Published - Dec 1996|