Large trial started for Viracept
Viracept, a new protease inhibitor awaiting Food and Drug Administration approval, will be studied in a large comparative trial conducted by the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA).
The 1,300-patient trial will evaluate the drug’s impact on disease progression and survival. Patients will take either viracept plus a nucleoside analogue or ritonavir plus a nucleoside analogue.
Enrollment for the year-long trial has begun at CPCRA sites throughout the United States.
As part of its application for FDA approval, viracept’s manufacturer, Agouron Pharmaceuticals of La Jolla, CA, has received permission to include children in its expanded access program, which makes the drug available to patients for whom no comparable or satisfactory therapy exists. Its new drug application covered both tablet and pediatric powder formulation. No pediatric formulations for protease inhibitors have yet been approved.