Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: Phase 1/2 study

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

Research output: Contribution to journalArticle

69 Citations (Scopus)

Abstract

The use of recombinant CD4-IgG2 in pediatric 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.

Original languageEnglish (US)
Pages (from-to)1774-1779
Number of pages6
JournalJournal of Infectious Diseases
Volume182
Issue number6
DOIs
StatePublished - Jan 1 2000

Fingerprint

HIV-1
Serum
RNA
Virus Diseases
Intravenous Infusions
CD4-IgG(2)
Therapeutics
Pediatrics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children : Phase 1/2 study. / Shearer, William T.; Israel, Robert J.; Starr, Stuart; Fletcher, Courtney V.; Wara, Diane; Rathore, Mobeen; Church, Joseph; DeVille, Jaime; Fenton, Terence; Graham, Bobbie; Samson, Pearl; Staprans, Silvija; McNamara, James; Moye, John; Maddon, Paul J.; Olson, William C.

In: Journal of Infectious Diseases, Vol. 182, No. 6, 01.01.2000, p. 1774-1779.

Research output: Contribution to journalArticle

Shearer, WT, Israel, RJ, Starr, S, Fletcher, CV, Wara, D, Rathore, M, Church, J, DeVille, J, Fenton, T, Graham, B, Samson, P, Staprans, S, McNamara, J, Moye, J, Maddon, PJ & Olson, WC 2000, 'Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: Phase 1/2 study', Journal of Infectious Diseases, vol. 182, no. 6, pp. 1774-1779. https://doi.org/10.1086/317622
Shearer, William T. ; Israel, Robert J. ; Starr, Stuart ; Fletcher, Courtney V. ; Wara, Diane ; Rathore, Mobeen ; Church, Joseph ; DeVille, Jaime ; Fenton, Terence ; Graham, Bobbie ; Samson, Pearl ; Staprans, Silvija ; McNamara, James ; Moye, John ; Maddon, Paul J. ; Olson, William C. / Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children : Phase 1/2 study. In: Journal of Infectious Diseases. 2000 ; Vol. 182, No. 6. pp. 1774-1779.
@article{88610f9eeed14d31aa420b1c5ad7690a,
title = "Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: Phase 1/2 study",
abstract = "The use of recombinant CD4-IgG2 in pediatric 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.",
author = "Shearer, {William T.} and Israel, {Robert J.} and Stuart Starr and Fletcher, {Courtney V.} and Diane Wara and Mobeen Rathore and Joseph Church and Jaime DeVille and Terence Fenton and Bobbie Graham and Pearl Samson and Silvija Staprans and James McNamara and John Moye and Maddon, {Paul J.} and Olson, {William C.}",
year = "2000",
month = "1",
day = "1",
doi = "10.1086/317622",
language = "English (US)",
volume = "182",
pages = "1774--1779",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "6",

}

TY - JOUR

T1 - Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children

T2 - Phase 1/2 study

AU - Shearer, William T.

AU - Israel, Robert J.

AU - Starr, Stuart

AU - Fletcher, Courtney V.

AU - Wara, Diane

AU - Rathore, Mobeen

AU - Church, Joseph

AU - DeVille, Jaime

AU - Fenton, Terence

AU - Graham, Bobbie

AU - Samson, Pearl

AU - Staprans, Silvija

AU - McNamara, James

AU - Moye, John

AU - Maddon, Paul J.

AU - Olson, William C.

PY - 2000/1/1

Y1 - 2000/1/1

N2 - The use of recombinant CD4-IgG2 in pediatric 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.

AB - The use of recombinant CD4-IgG2 in pediatric 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.

UR - http://www.scopus.com/inward/record.url?scp=0033712475&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033712475&partnerID=8YFLogxK

U2 - 10.1086/317622

DO - 10.1086/317622

M3 - Article

C2 - 11069253

AN - SCOPUS:0033712475

VL - 182

SP - 1774

EP - 1779

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 6

ER -