A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (Procysteine) in asymptomatic HIV-infected subjects

Robert C. Kalayjian, Gail Skowron, Rinchen Tzo Emgushov, Michael Chance, Sharon A. Spell, Peggy R. Borum, Lawrence S. Webb, Kenneth H. Mayer, J. Brooks Jackson, Belinda Yen-Lieberman, Kenneth O. Story, W. B. Rowe, Kathleen Thompson, Dennis Goldberg, Susan Trimbo, Michael M. Lederman

Research output: Contribution to journalArticlepeer-review

Abstract

Twenty-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.

Original languageEnglish (US)
Pages (from-to)369-374
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume7
Issue number4
StatePublished - 1994
Externally publishedYes

Keywords

  • Cysteine
  • Glutathione
  • N-Acetylcysteine

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)
  • Immunology and Allergy
  • Virology

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