Document 0248
 DOCN  M9460248
 TI    A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid
       (procysteine) in asymptomatic HIV-infected subjects.
 DT    9404
 AU    Kalayjian RC; Skowron G; Emgushov RT; Chance M; Spell SA; Borum PR; Webb
       LS; Mayer KH; Jackson JB; Yen-Lieberman B; et al; Department of
       Medicine, Case Western Reserve University School of; Medicine,
       University Hospitals of Cleveland, Ohio.
 SO    J Acquir Immune Defic Syndr. 1994 Apr;7(4):369-74. Unique Identifier :
       AIDSLINE MED/94180311
 AB    Twenty-four asymptomatic, HIV-1-seropositive subjects with CD4 cell
       counts of > or = 400/microliters participated in a Phase I/II, dose
       escalation trial of intravenous L-2-oxothiazolidine-4-carboxylic acid
       (OTC: Procysteine). Four groups of six subjects each were consecutively
       assigned to receive OTC at an initial dose of 3, 10, 30, or 100 mg/kg,
       followed by the same dose given twice weekly for 6 weeks. Increases in
       whole-blood glutathione were observed in the highest dosage group after
       6 weeks of therapy. No effects on changes in CD4 cell counts, viral
       load, or proviral DNA frequency were observed among the four dosage
       groups, although a decline in beta 2-microglobulin levels was apparent
       in the highest dosage group. One subject withdrew due to headaches;
       other probable adverse events including rash, flushing, pruritus,
       lightheadedness, and diminished concentration were self-limited.
 DE    beta 2-Microglobulin/ANALYSIS  Adult  Aged  Cysteine/BLOOD  Female
       Glutathione/BLOOD  Human  HIV Seropositivity/*DRUG THERAPY  Infusions,
       Intravenous  Leukocyte Count  Male  Middle Age  Support, Non-U.S. Gov't
       Support, U.S. Gov't, P.H.S.  Thiazoles/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/  PHARMACOKINETICS/*THERAPEUTIC USE  T4 Lymphocytes  CLINICAL
       TRIAL  CLINICAL TRIAL, PHASE I  CLINICAL TRIAL, PHASE II  JOURNAL
       ARTICLE  MULTICENTER STUDY

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