DESIGN AND IMPLEMENTATION OF THE STAVUDINE PARALLEL-TRACK PROGRAM

In a randomized, double-blind, large, simple trial, the safety and eff icacy of two weight-adjusted dose levels of stavudine were evaluated i n patients with advanced human immunodeficiency virus (HIV) infection. All patients were refractory to or intolerant of both zidovudine and didanosine. Patients weighing greater than or equal to 60 kg received 20 or 40 mg of stavudine twice daily. The dose was reduced to 15 or 30 mg for patients weighing 40-59 kg and to 10 or 20 mg for those weighi ng <40 kg. The primary efficacy end points were survival and time to c linical progression of HIV disease. The primary safety end point was t ime to dose-limiting neuropathy. A total of 8127 patients were enrolle d as of 31 July 1993. Although many patients who might have benefitted from stavudine were reached by the parallel-track program, a review o f demographic data revealed disproportionate representation by white m en from large metropolitan areas on both coasts.