A Phase I/II Trial of Intravenous L‐2-Oxothiazolidine‐4-carboxylic Acid (Procysteine) in Asymptomatic HIV‐Infected Subjects
作者:
Robert Kalayjian,
Gail Skowron,
Rinchen-Tzo Emgushov,
Michael Chance,
Sharon Spell,
Peggy Borum,
Lawrence Webb,
Kenneth Mayer,
J. Jackson,
Belinda Yen-Lieberman,
Kenneth Story,
W. Rowe,
Kathleen Thompson,
Dennis Goldberg,
Susan Trimbo,
Michael Lederman,
期刊:
Journal of Acquired Immune Deficiency Syndromes
(OVID Available online 1994)
卷期:
Volume 7,
issue 4
页码: 369-374
ISSN:0894-9255
年代: 1994
出版商: OVID
关键词: Glutathione;Cysteine;N-Acetylcysteine.
数据来源: OVID
摘要:
SummaryTwenty-four asymptomatic, HIV-1-seropositive subjects with CD4 cell counts of ≥400/μl 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 β2-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.
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