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M9550875.TXT
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1995-03-25
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Document 0875
DOCN M9550875
TI Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical
trials group 089.
DT 9505
AU Murray HW; Squires KE; Weiss W; Sledz S; Sacks HS; Hassett J; Cross A;
Anderson RE; Dunkle LM; Division of Infectious Diseases, Cornell
University Medical; College, New York, New York.
SO J Infect Dis. 1995 Mar;171 Suppl 2:S123-30. Unique Identifier : AIDSLINE
MED/95164988
AB 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.
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/IMMUNOLOGY/
PHYSIOPATHOLOGY Adult AIDS-Related Complex/*DRUG
THERAPY/IMMUNOLOGY/PHYSIOPATHOLOGY Body Weight CD4 Lymphocyte Count
Female Human HIV Core Protein p24/IMMUNOLOGY Male Middle Age
Peripheral Nervous System Diseases/CHEMICALLY INDUCED Proportional
Hazards Models Stavudine/ADVERSE EFFECTS/*THERAPEUTIC USE Support,
Non-U.S. Gov't Support, U.S. Gov't, P.H.S. Survival Analysis CLINICAL
TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).