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 co unts of greater than or equal to 400/mu l participated in a Phase VII, dose escalation trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (OTC: Procysteine). Four groups of six subjects each were consec utively assigned to receive OTC at an initial dose of 3, 10, 30, or 10 0 mg/kg, followed by the same dose given twice weekly for 6 weeks. Inc reases in whole-blood glutathione were observed in the highest dosage group after 6 weeks of therapy. No effects on changes in CD4 cell coun ts, 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 hea daches; other probable adverse events including rash, flushing, prurit us, lightheadedness, and diminished concentration were self-limited.