RANDOMIZED PHASE-I TRIAL OF 2 DIFFERENT COMBINATION FOSCARNET AND GANCICLOVIR CHRONIC MAINTENANCE THERAPY REGIMENS FOR AIDS PATIENTS WITH CYTOMEGALOVIRUS RETINITIS - AIDS-CLINICAL-TRIALS-GROUP PROTOCOL-151

AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis who had just completed a 14-day course of ganciclovir induction therapy w ere randomly assigned to an alternating or concurrent combination regi men of chronic ganciclovir-foscarnet therapy for CMV retinitis. Each r egimen used lower weekly cumulative doses of each drug than standard m onotherapy maintenance treatment regimens. Dose-limiting toxicity attr ibutable to foscarnet occurred in only 2 (7%) of 29 evaluatable patien ts, and no patients experienced dose-limiting nephrotoxicity. Although absolute neutrophil counts <500 cells/mu L occurred in 11 (38%) of 29 patients, all who subsequently used adjunctive granulocyte colony-sti mulating factor had severe neutropenia prevented. Severe toxicity of a ny type and neutropenia, in particular, occurred significantly more fr equently in patients assigned to the concurrent treatment regimen. CMV was isolated from none of 21 patients who had urine cultured and from only 1 of 24 who had blood cultured while being treated during the st udy (median evaluation, 12 weeks). This suggests that combination ther apy provides better in vivo antiviral activity in suppressing CMV repl ication than previously reported with monotherapy regimens.