Clinical trial of tolerance of HPA-23 in patients with acquired immune deficiency syndrome.
An open-label, multicenter clinical trial assessed the tolerance of HPA-23 (ammonium-21-tungsto-9-antimoniate) in patients with acquired immune deficiency syndrome. Sixty-nine patients were sequentially assigned to receive 0.25, 0.5, 1.0, or 2.0 mg of HPA-23 per kg intravenously 5 days per week for 8 weeks. HPA-23 was fairly well tolerated at doses of 1.0 mg/kg or less; nearly 60% of patients given 2.0 mg/kg discontinued treatment. Twenty-six patients discontinued treatment because of adverse events or concurrent illness. HPA-23 produced dose-related decreases in platelet count and increases in serum glutamine oxalacetic transaminase. There were no changes in immune system function, as determined by total lymphocyte count, T4-cell count, T8-cell count, and T4/T8 ratio. The effects of HPA-23 seemed to be more closely related to the total dose than to the daily dose. No improvement in the clinical status of the patients was observed during the 8 weeks of treatment.
Moskovitz
B L
BL
Clinical Research Division, Rhone-Poulenc Pharmaceuticals, Princeton, New Jersey 08543.
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy*; D000328:Adult; D000965:Antimony / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001772:Blood Cell Count / Q000187:drug effects; D002986:Clinical Trials as Topic; D004361:Drug Tolerance; D006801:Humans; D008297:Male; D010976:Platelet Count / Q000187:drug effects; D013601:T-Lymphocytes / Q000187:drug effects; D014414:Tungsten / Q000627:therapeutic use*; D017973:Tungsten Compounds
D000998:Antiviral Agents; D017973:Tungsten Compounds; C009613:ammonium tungsten antimonate hydroxide oxide; D000965:Antimony; D001219:Aspartate Aminotransferases; D014414:Tungsten