Design and implementation of the stavudine parallel-track program.
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.
Anderson
R E
RE
Bristol-Myers Squibb Co., Pharmaceutical Research Institute, Wallingford, Connecticut 06492.
Dunkle
L M
LM
Smaldone
L
L
Adler
M
M
Wirtz
C
C
Kriesel
D
D
Cross
A
A
Martin
R R
RR
D000328:Adult; D001835:Body Weight; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D012044:Regression Analysis; D018119:Stavudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate
D018119:Stavudine