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M9550874.TXT
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1995-03-25
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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).