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Passive hyperimmune plasma therapy in the treatment of acquired
immunodeficiency syndrome: results of a 12-month multicenter double- blind
controlled trial. The Passive Hyperimmune Therapy Study Group [see
comments]
J Levy, T Youvan and ML Lee
HemaCare Corporation, Sherman Oaks, CA 91403.
High-titer anti-human immunodeficiency virus (HIV) antibodies reduced
circulating HIV viral burden and has shown promise in previous small
uncontrolled studies, warranting a larger controlled study of passive
hyperimmune therapy (PHT) in persons with acquired immunodeficiency
syndrome (AIDS). The objective of this study was to determine the efficacy
and safety of PHT in 220 AIDS subjects in a 12-month double- blind
placebo-controlled dosing study. Subjects were randomized to receive
monthly infusions of 500 mL of plasma (full dose), 250 mL of plasma diluted
in 250 mL of 5% human serum albumin (half dose), or 500 mL of 5% human
serum albumin (placebo). Positive treatment effects occurred only in
full-dose-treated subjects with baseline CD4 cell counts between 50 and 200
cells/mm3. Reduced mortality was observed, 1 death in 21 (full dose) versus
3 deaths in 21 (half dose) and 6 deaths in 30 (placebo) (P = .065). CD4
cells improved an average of 32.7 cells/mm3 over baseline (full dose)
versus 0.9 cells/mm3 (half dose) and a loss of 3.5 cells/mm3 (placebo) (P =
.043). No adverse effects or toxicity was noted in donors or recipients.
Based on these findings, PHT appears to be a safe, promising therapy
warranting further study.
Volume 84,
Issue 7,
pp. 2130-2135,
10/01/1994
Copyright © 1994 by The American Society of Hematology
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