Design and implementation of the stavudine parallel-track program.

Abstract

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.

• Authors: R E Anderson, L M Dunkle, L Smaldone, M Adler, C Wirtz, D Kriesel, A Cross, R R Martin
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 171 Suppl 2 Pg. S118-22 (Mar 1995) ISSN: 0022-1899 [Print] United States
• PMID: 7861016 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Stavudine

Topics

• Adult
• Body Weight
• Double-Blind Method
• Female
• HIV Infections (drug therapy)
• Humans
• Male
• Peripheral Nervous System Diseases (chemically induced)
• Regression Analysis
• Stavudine (administration & dosage, adverse effects, therapeutic use)
• Survival Rate