A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (procysteine) in asymptomatic HIV-infected subjects
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...
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| Veröffentlicht in: | Journal of acquired immune deficiency syndromes (1988) 1994-04, Vol.7 (4), p.369-374 |
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| container_title | Journal of acquired immune deficiency syndromes (1988) |
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| creator | KALAYJIAN, R. C SKOWRON, G STORY, K. O ROWE, W. B THOMPSON, K GOLDBERG, S TRIMBO, S LEDERMAN, M. M EMGUSHOV, R.-T CHANCE, M SPELL, S. A BORUM, P. R WEBB, L. S MAYER, K. H JACKSON, J. B YEN-LIEBERMAN, B |
| description | 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. |
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C ; SKOWRON, G ; STORY, K. O ; ROWE, W. B ; THOMPSON, K ; GOLDBERG, S ; TRIMBO, S ; LEDERMAN, M. M ; EMGUSHOV, R.-T ; CHANCE, M ; SPELL, S. A ; BORUM, P. R ; WEBB, L. S ; MAYER, K. H ; JACKSON, J. B ; YEN-LIEBERMAN, B</creator><creatorcontrib>KALAYJIAN, R. C ; SKOWRON, G ; STORY, K. O ; ROWE, W. B ; THOMPSON, K ; GOLDBERG, S ; TRIMBO, S ; LEDERMAN, M. M ; EMGUSHOV, R.-T ; CHANCE, M ; SPELL, S. A ; BORUM, P. R ; WEBB, L. S ; MAYER, K. H ; JACKSON, J. B ; YEN-LIEBERMAN, B</creatorcontrib><description>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.</description><identifier>ISSN: 0894-9255</identifier><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 2331-2289</identifier><identifier>EISSN: 1944-7884</identifier><identifier>PMID: 7907662</identifier><identifier>CODEN: JAISET</identifier><language>eng</language><publisher>New York, NY: Raven Press</publisher><subject>Adult ; Aged ; Antibiotics. Antiinfectious agents. 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C</creatorcontrib><creatorcontrib>SKOWRON, G</creatorcontrib><creatorcontrib>STORY, K. O</creatorcontrib><creatorcontrib>ROWE, W. B</creatorcontrib><creatorcontrib>THOMPSON, K</creatorcontrib><creatorcontrib>GOLDBERG, S</creatorcontrib><creatorcontrib>TRIMBO, S</creatorcontrib><creatorcontrib>LEDERMAN, M. M</creatorcontrib><creatorcontrib>EMGUSHOV, R.-T</creatorcontrib><creatorcontrib>CHANCE, M</creatorcontrib><creatorcontrib>SPELL, S. A</creatorcontrib><creatorcontrib>BORUM, P. R</creatorcontrib><creatorcontrib>WEBB, L. S</creatorcontrib><creatorcontrib>MAYER, K. H</creatorcontrib><creatorcontrib>JACKSON, J. B</creatorcontrib><creatorcontrib>YEN-LIEBERMAN, B</creatorcontrib><title>A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (procysteine) in asymptomatic HIV-infected subjects</title><title>Journal of acquired immune deficiency syndromes (1988)</title><addtitle>J Acquir Immune Defic Syndr (1988)</addtitle><description>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. 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Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>beta 2-Microglobulin - analysis</subject><subject>Biological and medical sciences</subject><subject>CD4-Positive T-Lymphocytes</subject><subject>Cysteine - blood</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Glutathione - blood</subject><subject>HIV</subject><subject>HIV Seropositivity - drug therapy</subject><subject>Human immunodeficiency virus</subject><subject>human immunodeficiency virus 1</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Leukocyte Count</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. 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C</au><au>SKOWRON, G</au><au>STORY, K. O</au><au>ROWE, W. B</au><au>THOMPSON, K</au><au>GOLDBERG, S</au><au>TRIMBO, S</au><au>LEDERMAN, M. M</au><au>EMGUSHOV, R.-T</au><au>CHANCE, M</au><au>SPELL, S. A</au><au>BORUM, P. R</au><au>WEBB, L. S</au><au>MAYER, K. H</au><au>JACKSON, J. B</au><au>YEN-LIEBERMAN, B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (procysteine) in asymptomatic HIV-infected subjects</atitle><jtitle>Journal of acquired immune deficiency syndromes (1988)</jtitle><addtitle>J Acquir Immune Defic Syndr (1988)</addtitle><date>1994-04-01</date><risdate>1994</risdate><volume>7</volume><issue>4</issue><spage>369</spage><epage>374</epage><pages>369-374</pages><issn>0894-9255</issn><issn>1525-4135</issn><eissn>2331-2289</eissn><eissn>1944-7884</eissn><coden>JAISET</coden><abstract>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.</abstract><cop>New York, NY</cop><pub>Raven Press</pub><pmid>7907662</pmid><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0894-9255 |
| ispartof | Journal of acquired immune deficiency syndromes (1988), 1994-04, Vol.7 (4), p.369-374 |
| issn | 0894-9255 1525-4135 2331-2289 1944-7884 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_16922698 |
| source | MEDLINE; Journals@Ovid LWW Legacy Archive; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete; Free E- Journals |
| subjects | Adult Aged Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents beta 2-Microglobulin - analysis Biological and medical sciences CD4-Positive T-Lymphocytes Cysteine - blood Drug therapy Female Glutathione - blood HIV HIV Seropositivity - drug therapy Human immunodeficiency virus human immunodeficiency virus 1 Humans Infusions, Intravenous Leukocyte Count Male Medical research Medical sciences Middle Aged Pharmacology. Drug treatments Pyrrolidonecarboxylic Acid Thiazoles - administration & dosage Thiazoles - adverse effects Thiazoles - pharmacokinetics Thiazoles - therapeutic use Thiazolidines |
| title | A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (procysteine) in asymptomatic HIV-infected subjects |
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