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M9640757.TXT
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1996-03-04
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Document 0757
DOCN M9640757
TI The tolerability and pharmacokinetics of N-butyl-deoxynojirimycin in
patients with advanced HIV disease (ACTG 100). The AIDS Clinical Trials
Group (ACTG) of the National Institute of Allergy and Infectious
Diseases.
DT 9604
AU Tierney M; Pottage J; Kessler H; Fischl M; Richman D; Merigan T;
Powderly W; Smith S; Karim A; Sherman J; et al; Massachusetts General
Hospital, Boston 02114, USA.
SO J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Dec 15;10(5):549-53.
Unique Identifier : AIDSLINE MED/96142217
AB Twenty-nine patients were enrolled in a phase I dose-escalating
tolerance trial of N-butyl-deoxynojirimycin, an alpha-glucosidase I
inhibitor that inhibits human immunodeficiency virus (HIV)-1 replication
by altering glycosylation of gp120. Dosing was begun at 8 mg/kg/day and
subsequent doses were 16, 32, 48, and 64 mg/kg/day. The maximum
tolerated dose was not achieved because of slow accrual and because the
study was stopped after the finding of cataracts in initial long-range
rat toxicology studies. These cataracts were later shown to be transient
and not found in other animals. The most common side effects were
gastrointestinal, with diarrhea and flatulence occurring in most
subjects, which seemed to partially improve on a modified diet that
excluded complex carbohydrates. Grade III elevations in liver function
tests were seen in two patients. Grade III leukopenia and neutropenia
were seen in seven patients, but were only severe enough in two to
require discontinuation. No significant trends in CD4 cell counts or
HIV-1 p24 levels were noted.
DE Adult Animal Antiviral Agents/ADVERSE EFFECTS/*PHARMACOKINETICS
Cataract/CHEMICALLY INDUCED CD4 Lymphocyte Count CD4-Positive
T-Lymphocytes/IMMUNOLOGY Diarrhea/CHEMICALLY INDUCED Female
Flatulence/CHEMICALLY INDUCED Half-Life Human HIV Core Protein
p24/ANALYSIS HIV Infections/IMMUNOLOGY/*METABOLISM *HIV-1 Lens,
Crystalline/DRUG EFFECTS Leukopenia/CHEMICALLY INDUCED Liver/DRUG
EFFECTS Male Neutropenia/CHEMICALLY INDUCED Rats
1-Deoxynojirimycin/*ANALOGS & DERIVATIVES/ADVERSE EFFECTS/
PHARMACOKINETICS CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL
ARTICLE MULTICENTER STUDY
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).