GILEAD VISTIDE PHASE IV STUDIES TO ADDRESS COMBO THERAPY WITH ORAL CYTOVENEOR GILEAD's ADEFOVIR; TAG CALLS FOR ACTIVE CONTROLS IN CMV RETINITIS TRIALS
Executive Summary
Gilead Pharmaceuticals will conduct Phase IV trials to assess combinations of Vistide (cidofovir I.V.) and oral maintenance therapies on the progression of cytomegalovirus retinitis, Gilead VP-Clinical Affairs Howard Jaffe, MD, told FDA's Antiviral Drugs Advisory Committee and Ophthalmic Drugs Subcommittee March 15. The committees unanimously recommended approval of Vistide (NDA 20-638) ("The Pink Sheet" March 18, p. 5).