       Document 0877
 DOCN  M9550877
 TI    Biologic effects and safety of stavudine: overview of phase I and II
       clinical trials.
 DT    9505
 AU    Skowron G; Roger Williams Medical Center, Brown University School of;
       Medicine, Providence, Rhode Island 02908.
 SO    J Infect Dis. 1995 Mar;171 Suppl 2:S113-7. Unique Identifier : AIDSLINE
       MED/95164986
 AB    Data on the biologic effects and safety of stavudine in patients with
       AIDS and AIDS-related complex represent results of two phase I trials (n
       = 84), another phase I study of patients with hematologic intolerance to
       zidovudine (n = 23), and a phase II trial (n = 152). The daily doses of
       stavudine ranged from 0.1 to 12.0 mg/kg. Increases in CD4 cell count,
       declines in serum p24 antigen, and weight gain were all related to the
       dose of stavudine. Doses of < or = 2 mg/kg/day (n = 216) were
       well-tolerated, with a median duration of therapy of > or = 48 weeks in
       the phase I studies and > or = 79 weeks in the phase II study. The
       predominant dose-limiting toxicity was peripheral neuropathy, which was
       related to both the dose and duration of treatment with stavudine.
       Elevations of liver enzymes were seen in some patients but appeared to
       be related to underlying disease rather than treatment. There was no
       evidence of dose-related hematologic toxicity.
 DE    Acquired Immunodeficiency Syndrome/DRUG THERAPY  AIDS-Related
       Complex/DRUG THERAPY  Body Weight/DRUG EFFECTS  Clinical Trials, Phase I
       Clinical Trials, Phase II  CD4 Lymphocyte Count/DRUG EFFECTS
       Dose-Response Relationship, Drug  Human  HIV Core Protein p24/DRUG
       EFFECTS/IMMUNOLOGY  HIV Infections/*DRUG
       THERAPY/IMMUNOLOGY/PHYSIOPATHOLOGY  Peripheral Nervous System
       Diseases/CHEMICALLY INDUCED  Stavudine/ADMINISTRATION & DOSAGE/*ADVERSE
       EFFECTS/THERAPEUTIC  USE  Support, Non-U.S. Gov't  Support, U.S. Gov't,
       P.H.S.  JOURNAL ARTICLE  REVIEW  REVIEW, TUTORIAL

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

