Document 0691
 DOCN  M9440691
 TI    The safety and efficacy of combination N-butyl-deoxynojirimycin
       (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500
       CD4 cells/mm3.
 DT    9404
 AU    Fischl MA; Resnick L; Coombs R; Kremer AB; Pottage JC Jr; Fass RJ; Fife
       KH; Powderly WG; Collier AC; Aspinall RL; et al; University of Miami
       School of Medicine, Florida.
 SO    J Acquir Immune Defic Syndr. 1994 Feb;7(2):139-47. Unique Identifier :
       AIDSLINE MED/94133083
 AB    We conducted a double-blind, randomized phase II study to evaluate the
       safety and activity of combination therapy with N-butyl-deoxynojirimycin
       (SC-48334) (an alpha-glucosidase I inhibitor) and zidovudine versus
       zidovudine alone. Patients with 200 to 500 CD4 cells/mm3 who tolerated <
       or = 12 weeks of prior zidovudine therapy received SC-48334 (1000 mg
       every 8 h) and zidovudine (100 mg every 8 h) or zidovudine and placebo.
       Sixty patients received combination therapy and 58, zidovudine and
       placebo. Twenty-three patients (38%) and 15 (26%), in the combination
       and zidovudine groups, respectively, discontinued therapy (p = 0.15).
       The mean SC-48334 steady-state trough level (4.04 +/- 0.99
       micrograms/ml) was below the in vitro inhibitory concentration for human
       immunodeficiency virus (HIV). The mean increase in CD4 cells at week 4
       was 73.8 cells/mm3 and 52.4 cells/mm3 for the combination and zidovudine
       groups, respectively (p > 0.36). For patients with prior zidovudine
       therapy, the mean change in CD4 cells in the combination and zidovudine
       groups was 63.7 cells/mm3 and 4.9 cells/mm3 at week 8 and 6.8 cells/mm3
       and 45.1 cells/mm3 at week 16, respectively. The number of patients with
       suppression of HIV p24 antigenemia in the combination and zidovudine
       groups was six (40%) and two (11%) at week 4 (p = 0.10) and five (45%)
       and two (14%) at week 24 (p = 0.08), respectively. Diarrhea, flatulence,
       abdominal pain, and weight loss were common for combination
       recipients.(ABSTRACT TRUNCATED AT 250 WORDS)
 DE    beta 2-Microglobulin/ANALYSIS  Adult  Antiviral Agents/ADVERSE
       EFFECTS/PHARMACOKINETICS/*THERAPEUTIC  USE  Diarrhea/CHEMICALLY INDUCED
       Double-Blind Method  Drug Therapy, Combination  Female  Follow-Up
       Studies  Hemoglobins/ANALYSIS  Human  HIV Core Protein p24/BLOOD  HIV
       Infections/*DRUG THERAPY/IMMUNOLOGY  *HIV-1/DRUG EFFECTS/GENETICS
       Leukocyte Count  Male  Neutrophils/DRUG EFFECTS  Paresthesia/CHEMICALLY
       INDUCED  RNA, Viral/BLOOD  Support, Non-U.S. Gov't  T4
       Lymphocytes/CYTOLOGY  Zidovudine/ADVERSE
       EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE  1-Deoxynojirimycin/*ANALOGS &
       DERIVATIVES/ADVERSE EFFECTS/  PHARMACOKINETICS/THERAPEUTIC USE  CLINICAL
       TRIAL  CLINICAL TRIAL, PHASE II  JOURNAL ARTICLE  RANDOMIZED CONTROLLED
       TRIAL

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       protected by Copyright Law (Title 17, U.S.Code).