Document 0876
 DOCN  M9550876
 TI    Design and implementation of the stavudine parallel-track program.
 DT    9505
 AU    Anderson RE; Dunkle LM; Smaldone L; Adler M; Wirtz C; Kriesel D; Cross
       A; Martin RR; Bristol-Myers Squibb Co., Pharmaceutical Research
       Institute,; Wallingford, Connecticut 06492.
 SO    J Infect Dis. 1995 Mar;171 Suppl 2:S118-22. Unique Identifier : AIDSLINE
       MED/95164987
 AB    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.
 DE    Adult  Body Weight  Double-Blind Method  Female  Human  HIV
       Infections/*DRUG THERAPY  Male  Peripheral Nervous System
       Diseases/CHEMICALLY INDUCED  Regression Analysis
       Stavudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       Support, Non-U.S. Gov't  Survival Rate  CLINICAL TRIAL  JOURNAL ARTICLE
       RANDOMIZED CONTROLLED TRIAL

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