Pediatric Trial of 141W94, Vertex Protease Inhibitor

A new trial of the protease inhibitor 141W94 (formerly called VX-478) is seeking 210 children and adolescents between 6 months and 18 years old. They must have a viral load of at least 10,000 copies, and must not have taken protease inhibitors before. They will be randomly assigned to receive either the drug or a placebo, in addition to nucleoside analog treatment. This trial will look primarily for the size of the antiviral effect at 16 weeks, and its durability at 48 weeks. It will take place at medical centers in the U.S., Canada, and Europe. Another phase III study in adults started in February 1997.

141W94 is taken twice a day, without regard to food.

This phase III study should not be confused with an earlier Phase I single-dose study of the same drug, in 20 HIV-infected children.

For more information about trials in the U.S., physicians and parents will be able to call the AIDS Clinical Trials Information Service, 800/TRIALS-A.