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 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.
Kalayjian
R C
RC
Department of Medicine, Case Western Reserve University School of Medicine, University Hospitals of Cleveland, Ohio.
Skowron
G
G
Emgushov
R T
RT
Chance
M
M
Spell
S A
SA
Borum
P R
PR
Webb
L S
LS
Mayer
K H
KH
Jackson
J B
JB
Yen-Lieberman
B
B
D000328:Adult; D000368:Aged; D015496:CD4-Positive T-Lymphocytes; D003545:Cysteine / Q000097:blood; D005260:Female; D005978:Glutathione / Q000097:blood; D006679:HIV Seropositivity / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011761:Pyrrolidonecarboxylic Acid; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D053778:Thiazolidines; D001613:beta 2-Microglobulin / Q000032:analysis
D013844:Thiazoles; D053778:Thiazolidines; D001613:beta 2-Microglobulin; D005978:Glutathione; D003545:Cysteine; D011761:Pyrrolidonecarboxylic Acid; C029536:2-oxothiazolidine-4-carboxylic acid