FDA/NIAID discussion of DDC

FDA Commissioner Young and top officials from Center for Biologics Evaluation and Research met March 2 with National Institute of Allergy & Infectious Diseases (NIAID) AIDS Program Director Daniel Hoth, PhD, and representatives from Hoffmann-LaRoche to discuss progress of AIDS drug dideoxycytidine (DDC). The Roche drug is in Phase II trials at NIAID and the National Cancer Institute (NCI). NIAID trials at 11 centers involve a DDC/AZT combination, while the NCI trial is looking at alternating administration of the two drugs. Feb. 1 Annals of Internal Medicine study reports that DDC decreased serum p24 antigen in most of 61 AIDS or ARC patients enrolled in Phase I/II dose-ranging test.