Dose-related activity of stavudine in patients infected with human immunodeficiency virus.
In a multicenter, randomized, open-label, dose-ranging study to determine the relative effects of three dose levels of stavudine on CD4 lymphocyte count, weight gain, and hematologic variables in patients infected with human immunodeficiency virus (HIV), 152 patients with CD4 lymphocyte counts < or = 600/mm3 received stavudine at 0.1 mg/kg/day (n = 51), 0.5 mg/kg/day (n = 53), or 2.0 mg/kg/day (n = 48). The study was designed to evaluate the activity of stavudine after 10 weeks of therapy and permitted extended dosing and follow-up for long-term safety. A significant dose effect on increases in CD4 lymphocyte counts and declines in HIV titer in peripheral blood mononuclear cells was observed. Stavudine was well-tolerated; the only dose-related, dose-limiting adverse event was peripheral neuropathy, which usually was reversible. In this trial, the most favorable therapeutic index was seen at 0.5 mg/kg/day.
Petersen
E A
EA
Dept. of Medicine, University of Arizona, Tucson 85724.
Ramírez-Ronda
C H
CH
Hardy
W D
WD
Schwartz
R
R
Sacks
H S
HS
Follansbee
S
S
Peterson
D M
DM
Cross
A
A
Anderson
R E
RE
Dunkle
L M
LM
D000328:Adult; D000368:Aged; D018791:CD4 Lymphocyte Count; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006678:HIV / Q000276:immunology; D016655:HIV Core Protein p24 / Q000276:immunology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D018119:Stavudine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016019:Survival Analysis; D015430:Weight Gain
D016655:HIV Core Protein p24; D018119:Stavudine