Document 0874
 DOCN  M9550874
 TI    Dose-related activity of stavudine in patients infected with human
       immunodeficiency virus.
 DT    9505
 AU    Petersen EA; Ramirez-Ronda CH; Hardy WD; Schwartz R; Sacks HS;
       Follansbee S; Peterson DM; Cross A; Anderson RE; Dunkle LM; Dept. of
       Medicine, University of Arizona, Tucson 85724.
 SO    J Infect Dis. 1995 Mar;171 Suppl 2:S131-9. Unique Identifier : AIDSLINE
       MED/95164989
 AB    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.
 DE    Adult  Aged  CD4 Lymphocyte Count  Dose-Response Relationship, Drug
       Drug Administration Schedule  Female  Human  HIV/IMMUNOLOGY  HIV Core
       Protein p24/IMMUNOLOGY  HIV Infections/*DRUG
       THERAPY/IMMUNOLOGY/PHYSIOPATHOLOGY  Male  Middle Age  Peripheral Nervous
       System Diseases/CHEMICALLY INDUCED  Stavudine/*ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/THERAPEUTIC  USE  Support, Non-U.S. Gov't
       Survival Analysis  Weight Gain  CLINICAL TRIAL  CLINICAL TRIAL, PHASE II
       JOURNAL ARTICLE  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).