Design and implementation of the stavudine parallel-track program.

Author(s): Anderson RE, Dunkle LM, Smaldone L, Adler M, Wirtz C, Kriesel D, Cross A, Martin RR

Affiliation(s): Bristol-Myers Squibb Co., Pharmaceutical Research Institute, Wallingford, Connecticut 06492.

Publication date & source: 1995-03, J Infect Dis., 171 Suppl 2:S118-22.

Publication type: Clinical Trial; Randomized Controlled Trial

In a randomized, double-blind, large, simple trial, the safety and efficacy of two weight-adjusted dose levels of stavudine were evaluated in patients with advanced human immunodeficiency virus (HIV) infection. All patients were refractory to or intolerant of both zidovudine and didanosine. Patients weighing > or = 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 weighing < 40 kg. The primary efficacy end points were survival and time to clinical progression of HIV disease. The primary safety end point was time to dose-limiting neuropathy. A total of 8127 patients were enrolled as of 31 July 1993. Although many patients who might have benefitted from stavudine were reached by the parallel-track program, a review of demographic data revealed disproportionate representation by white men from large metropolitan areas on both coasts.