Skip Navigation LinksHome > October 1, 1995 - Volume 10 - Issue 2 > Safety, Pharmacokinetics, and Antiviral Response of CD4-Immu...
Journal of Acquired Immune Deficiency Syndromes & Human Retrovirology:

Safety, Pharmacokinetics, and Antiviral Response of CD4-Immunoglobulin G by Intravenous Bolus in AIDS and AIDS-Related Complex.

Collier, Ann C.; Coombs, Robert W.; Katzenstein, David; Holodniy, Mark; Gibson, Joel; Mordenti, Joyce; Izu, Allen E.; Duliege, Anne Marie; Ammann, Arthur J.; Merigan, Thomas; Corey, Lawrence

Collapse Box


Summary: To assess the safety, pharmacokinetics, and antiviral effects of intravenous recombinant CD4 immunoglobulin G (CD4-IgG), a 12-week Phase One study with an optional maintenance phase was performed. Twenty-two subjects with advanced human immunodeficiency virus (HIV) infection were enrolled; 15 subjects completed the initial 12 weeks. CD4-IgG doses were 30, 100, or 300 [mu]g/kg weekly; 1,000 [mu]g/kg once, twice, or three times per week; or 3,000 [mu]g/kg twice weekly. Serum concentrations of CD4-IgG increased linearly with dose, with average peak serum concentrations of 22 [mu]g/ml with 1,000 [mu]g/kg. CD4-IgG was well tolerated; one patient had self-limited tachycardia and flushing associated with CD4-IgG therapy. No changes were seen in CD4 cell counts, hematologic or coagulation studies, serum chemistries, HIV p24 antigen titers, or plasma HIV titers. No subject developed anti-CD4 antibodies. HIV isolates from five patients had IC90 values that were higher than the peak concentrations of CD4-IgG achieved in those patients. Additional studies that achieve higher CD4-IgG concentrations are necessary to evaluate the antiviral activity of this compound.

(C) Lippincott-Raven Publishers.


Article Tools


Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.