Journal Article

Recombinant CD4-IgG2 in Human Immunodeficiency Virus Type 1—Infected Children: Phase 1/2 Study

Rathore, Mobeen, Maddon, Paul J., Starr, Stuart, Samson, Pearl, McNamara, James, Olson, William C., Graham, Bobbie, Shearer, William T., Staprans, Silvija, Moye, John, DeVille, Jaime, Wara, Diane, Fenton, Terence, Israel, Robert J., Fletcher, Courtney V., Church, Joseph

2000

Overview

The use of recombinant CD4-IgG2 in pediatrie human immunodeficiency virus type 1 (HIV-1) infection was evaluated by single and multidose intravenous infusions in 18 children in a phase 1/2 study. The study drug was well tolerated, and dose proportionality was observed in terms of area under time-concentration curve and peak serum concentration. Acute decreases of >0.7 log10 copies/mL in serum HIV-1 RNA concentration were seen in 4 of the 6 children treated with 4 weekly 10 mg/kg doses. At 14 days after treatment, 3 children had sustained reductions in serum HIV-1 RNA; the other children had rebounded to baseline levels or above. By 28 days after therapy, the peak HIV-1 cellular infectious units was reduced in all 6 children, including the 2 who had experienced an earlier transient increase in values. Thus, recombinant CD4-IgG2 treatment of HIV-1—infected children appears to be well tolerated and capable of reducing HIV-1 burden.

• Publisher: The University of Chicago Press,University of Chicago Press,Oxford University Press
• Subject: AIDS / Antibacterial agents / Antibiotics. Antiinfectious agents. Antiparasitic agents / Biological and medical sciences / Child health services / Clinical trials / Concise Communications / Dosage / HIV / HIV 1 / Human immunodeficiency virus 1 / Human viral diseases / Infectious diseases / Medical sciences / Molecules / Pediatrics / Pharmacokinetics / Pharmacology. Drug treatments / RNA / Viral diseases / Viral diseases of the lymphoid tissue and the blood. Aids