SAFETY AND TOLERABILITY OF ZALCITABINE (DDC) IN PATIENTS WITH AIDS ORADVANCED AIDS-RELATED COMPLEX IN THE EUROPEAN EXPANDED ACCESS PROGRAM

This international expanded access programme was initiated to provide zalcitabine (o 75 mg three times daily) to patients with AIDS or advan ced ARC who had failed, were no longer able to tolerate or were inelig ible to receive zidovudine (ZDV). Data are available from 517 patients . No unexpected adverse events occurred during the study with 13.2% of patients discontinuing treatment due to drug-related adverse events. Peripheral neuropathy (PN) was the most common adverse event reported. This was considered to be at least possibly related to zalcitabine in 12.2% of patients, with only 2.3% of patients withdrawing from the st udy due to zalcitabine-associated PN. Patients with a baseline diagnos is of AIDS and a CD4 count less than or equal to 50 cells/mm(3) were m ost likely to develop PN on zalcitabine. Fifty-seven patients (11%) di ed during the study, with death considered to be at least remotely rel ated to therapy in only 2 cases (1 case each of pancreatitis and cereb ral toxoplasmosis with possible sepsis/granulocytopenia).