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A Phase I/IIA Clinical Study With A Chimeric Mouse-Human Monoclonal Antibody To The V3 Loop Of Human Immunodeficiency Virus Type 1 Gp120


Gunthard, H F; Gowland, P L; Schupbach, J; Fung, M S C; Boni, J; Liou, R-S; Chang, N T; Grob, P; Graepel, P; Braun, D G; Luthy, R (1994). A Phase I/IIA Clinical Study With A Chimeric Mouse-Human Monoclonal Antibody To The V3 Loop Of Human Immunodeficiency Virus Type 1 Gp120. Journal of Infectious Diseases, 170(6):1384-1393.

Abstract

A phase I/IIA clinical trial with the chimeric mouse-human monoclonal antibody CGP 47 439 to the principal neutralization determinant in the V3 region of human immunodeficiency virus type 1 (HIV-1) strain IIIB envelope protein gp 120 is reported. The trial was an uncontrolled single-center, open-label, multidose tolerability, immunogenicity, and pharmacokinetic study in homosexual men with advanced HIV disease. Patient groups were formed on the basis of the reactivity of the antibody with the gp 120 of their HIV-1 isolates. Intravenous infusions of 1, 10, and 25 mg of antibody were followed by seven escalated doses of 50, 100, and 200 mg, every 3 weeks. The antibody was well tolerated; no toxicity was observed. Some patients showed a transient but insignificant antibody response to the antibody with no apparent adverse reactions or accelerated elimination of it. Substantial serum levels of the antibody were maintained with a mean t1/2β of 8-16 days. A virus burden reduction was observed in some patients

Abstract

A phase I/IIA clinical trial with the chimeric mouse-human monoclonal antibody CGP 47 439 to the principal neutralization determinant in the V3 region of human immunodeficiency virus type 1 (HIV-1) strain IIIB envelope protein gp 120 is reported. The trial was an uncontrolled single-center, open-label, multidose tolerability, immunogenicity, and pharmacokinetic study in homosexual men with advanced HIV disease. Patient groups were formed on the basis of the reactivity of the antibody with the gp 120 of their HIV-1 isolates. Intravenous infusions of 1, 10, and 25 mg of antibody were followed by seven escalated doses of 50, 100, and 200 mg, every 3 weeks. The antibody was well tolerated; no toxicity was observed. Some patients showed a transient but insignificant antibody response to the antibody with no apparent adverse reactions or accelerated elimination of it. Substantial serum levels of the antibody were maintained with a mean t1/2β of 8-16 days. A virus burden reduction was observed in some patients

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Item Type:Journal Article, refereed, original work
Communities & Collections:National licences > 142-005
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Scopus Subject Areas:Health Sciences > Immunology and Allergy
Health Sciences > Infectious Diseases
Language:English
Date:1 December 1994
Deposited On:12 Oct 2018 13:04
Last Modified:15 Apr 2021 14:51
Publisher:Oxford University Press
ISSN:0022-1899
OA Status:Green
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1093/infdis/170.6.1384

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