Abstract |
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.
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Authors | J Levy, T Youvan, M L Lee |
Journal | Blood
(Blood)
Vol. 84
Issue 7
Pg. 2130-5
(Oct 01 1994)
ISSN: 0006-4971 [Print] United States |
PMID | 7919326
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- HIV Antibodies
- HIV Core Protein p24
- HIV hyperimmune globulin
- Immunoglobulins, Intravenous
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Topics |
- Acquired Immunodeficiency Syndrome
(therapy)
- CD4 Lymphocyte Count
- CD4-Positive T-Lymphocytes
- Dose-Response Relationship, Immunologic
- HIV Antibodies
(analysis)
- HIV Core Protein p24
(immunology)
- Humans
- Immunoglobulins, Intravenous
(administration & dosage)
- Immunotherapy
- Survival Analysis
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