       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).

