Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical trials group 089.
In a phase I trial of stavudine in AIDS or AIDS-related complex (ARC), antiviral effects and safety were assessed in 41 patients treated with dosages of 0.5-12.0 mg/kg/day. Among evaluable patients, 10% increases in CD4 lymphocyte counts were sustained in 24 (60%) of 40 during treatment; an NAUC response (normalized area under the CD4 cell count-versus-time curve > 1.0) was observed in 31 (91%) of 34 at 10 weeks and in 20 (80%) of 25 at 24 weeks; 15 (83%) of 18 had decreases in p24 antigenemia; and 24 (60%) of 40 gained > or = 2.5 kg body weight. Median CD4 lymphocyte levels remained above baseline for 6 months in patients receiving > 0.5 mg/kg/day. Median serum p24 antigen levels remained below baseline for > or = 1 year in patients with p24 antigen responses. The principal toxicity was peripheral neuropathy, which generally resolved after drug discontinuation but limited the dosage to < or = 2.0 mg/kg/day. Additional trials assessing the effect of stavudine on overall morbidity and mortality are ongoing.
Murray
H W
HW
Division of Infectious Diseases, Cornell University Medical College, New York, New York.
Squires
K E
KE
Weiss
W
W
Sledz
S
S
Sacks
H S
HS
Hassett
J
J
Cross
A
A
Anderson
R E
RE
Dunkle
L M
LM
D000386:AIDS-Related Complex / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D000328:Adult; D001835:Body Weight; D018791:CD4 Lymphocyte Count; D005260:Female; D016655:HIV Core Protein p24 / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D016016:Proportional Hazards Models; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
D016655:HIV Core Protein p24; D018119:Stavudine