Hoffmann-La Roche Inc. said it has discontinued a clinical trialcomparing its Hivid ddC (dideoxycytidine) with Retrovir AZT inpatients with AIDS and AIDS-Related Complex because ofdisappointing results with ddC.
Patients in the study had no prior AZT use or three months orless of AZT use. A one-year interim analysis of the data showed59 deaths of patients on Hivid out of 320 patients, and 33deaths of patients on Retrovir out of 315 patients.
The Nutley, N.J., company said the patient population in thediscontinued study is not the same as the patient populationfor the indications requested in its October application for Foodand Drug Administration marketing approval. Roche isrequesting approval of Hivid for patients with AIDS or ARCwho are intolerant or have failed AZT; and in combination withAZT as a first-line therapy for AIDS and ARC patients.
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