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

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 journal › Article › peer-review

39 Scopus citations

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 language	English (US)
Pages (from-to)	369-374
Number of pages	6
Journal	Journal of Acquired Immune Deficiency Syndromes
Volume	7
Issue number	4
State	Published - 1994
Externally published	Yes

Keywords

Cysteine
Glutathione
N-Acetylcysteine

ASJC Scopus subject areas

Infectious Diseases
Pharmacology (medical)
Immunology and Allergy
Virology

Cite this

Kalayjian, R. C., Skowron, G., Emgushov, R. T., Chance, M., Spell, S. A., Borum, P. R., Webb, L. S., Mayer, K. H., Jackson, J. B., Yen-Lieberman, B., Story, K. O., Rowe, W. B., Thompson, K., Goldberg, D., Trimbo, S., & Lederman, M. M. (1994). A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (Procysteine) in asymptomatic HIV-infected subjects. Journal of Acquired Immune Deficiency Syndromes, 7(4), 369-374.

Kalayjian, RC, Skowron, G, Emgushov, RT, Chance, M, Spell, SA, Borum, PR, Webb, LS, Mayer, KH, Jackson, JB, Yen-Lieberman, B, Story, KO, Rowe, WB, Thompson, K, Goldberg, D, Trimbo, S & Lederman, MM 1994, 'A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (Procysteine) in asymptomatic HIV-infected subjects', Journal of Acquired Immune Deficiency Syndromes, vol. 7, no. 4, pp. 369-374.

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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.",

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AU - Mayer, Kenneth H.

AU - Jackson, J. Brooks

AU - Yen-Lieberman, Belinda

AU - Story, Kenneth O.

AU - Rowe, W. B.

AU - Thompson, Kathleen

AU - Goldberg, Dennis

AU - Trimbo, Susan

AU - Lederman, Michael M.

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

Abstract

Keywords

ASJC Scopus subject areas

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