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M9550876.TXT
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1995-03-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).