PHARMACOKINETICS OF HYPERIMMUNE ANTI-HUMAN-IMMUNODEFICIENCY-VIRUS IMMUNOGLOBULIN IN PERSONS WITH AIDS

Hyperimmune anti-human immunodeficiency virus immunoglobulin (HIVIG) i s an intravenous immunoglobulin prepared from HIV-infected asymptomati c donors with a CD4 cell count greater than 400 cells/mu l and a high titer of antibody to HIV-1 p24 protein. Twelve persons with AIDS recei ved four doses of HMG (two at 50 mg/kg of body weight and then two at 200 mg/kg) every 28 days, Pharmacokinetics were evaluated by measureme nt of anti-p24 antibody. HIVIG was well tolerated, and all Participant s completed the study. Three subjects who were not receiving Pneumocys tis carinii pneumonia (PCP) prophylaxis developed PCP, The mean value for HMG clearance was 3.02 ml/kg/day at 50 mg/kg and 3.65 ml/kg/day at 200 mg/kg (P = 0.027); the mean trough antibody titers (reciprocal un its) were 1,442 and 4,428, respectively. This study indicates that hig h titers of anti-p24 antibody can be maintained with a monthly adminis tration Schedule of HMG and that short-term safety is acceptable. Comp arisons to evaluate the therapeutic potential of HIVIG are justified.