Intravenous Immune Globulin for the Prevention of Bacterial Infections in Children with Symptomatic Human Immunodeficiency Virus Infection

The National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group

Research output: Contribution to journalArticle

219 Citations (Scopus)

Abstract

Serious recurrent bacterial infections are a major cause of morbidity and mortality in children infected with the human immunodeficiency virus (HIV). Because intravenous immune globulin has been shown to prevent bacterial infection in patients with primary immunodeficiency and in uncontrolled studies of HIV-infected children, we undertook a multicenter study of its safety and efficacy in children with symptomatic HIV infection. In a double-blind trial, 372 HIV-infected children (mean age, 40 months) with clinical or immunologic evidence of HIV disease were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) or placebo (0.1 percent albumin) every 28 days. The children were stratified into two groups according to CD4+ lymphocyte count at entry into the study and the clinical classification of the Centers for Disease Control. The median length of follow-up was 17 months. For children in either group with CD4+ counts ≥0.2×109 per liter (≥200 per cubic millimeter) at entry, treatment with intravenous immune globulin significantly increased the time free from serious infection; estimated infection-free rates after 24 months were 67 percent for children receiving immune globulin as compared with 48 percent for those receiving placebo (P = 0.01 ). In addition, immune globulin was associated with an overall reduction in the number of both serious and minor bacterial infections (relative risk, 0.68; P = 0.01) and in the number of hospitalizations for acute care (relative risk, 0.65; P = 0.03). No such benefits were seen for children with CD4+ counts below 0.2×109 per liter at entry. For group 1 overall, there was a trend toward a difference in serious bacterial infection between immune globulin and placebo (24-month infection-free survival, 31 percent for intravenous immune globulin vs. 25 percent for placebo; P = 0.10). For group 2, the estimates of survival without serious infection were 73 percent with intravenous immune globulin as compared with 53 percent with placebo (P = 0.04). There was no effect of treatment on mortality for any group or CD4+ count at entry. Adverse reactions, noted for less than 1 percent of infusions, were minor. In symptomatic HIV-infected children the prophylactic use of intravenous immune globulin is safe, and it significantly increases the time free from serious bacterial infections for those entering treatment with CD4+ lymphocyte counts ≥0.2×109 per liter. (N Engl J Med 1991; 325:73–80.)

Original languageEnglish (US)
Pages (from-to)73-80
Number of pages8
JournalNew England Journal of Medicine
Volume325
Issue number2
DOIs
StatePublished - Jul 11 1991
Externally publishedYes

Fingerprint

Intravenous Immunoglobulins
Virus Diseases
Bacterial Infections
HIV
CD4 Lymphocyte Count
Placebos
Immunoglobulins
Infection
Child Mortality
Centers for Disease Control and Prevention (U.S.)
Multicenter Studies
Albumins
Hospitalization
Therapeutics
Body Weight
Morbidity
Safety
Mortality

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Intravenous Immune Globulin for the Prevention of Bacterial Infections in Children with Symptomatic Human Immunodeficiency Virus Infection. / The National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group.

In: New England Journal of Medicine, Vol. 325, No. 2, 11.07.1991, p. 73-80.

Research output: Contribution to journalArticle

The National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group. / Intravenous Immune Globulin for the Prevention of Bacterial Infections in Children with Symptomatic Human Immunodeficiency Virus Infection. In: New England Journal of Medicine. 1991 ; Vol. 325, No. 2. pp. 73-80.
@article{d98a46f42c3c40de9fcf1373cd06b528,
title = "Intravenous Immune Globulin for the Prevention of Bacterial Infections in Children with Symptomatic Human Immunodeficiency Virus Infection",
abstract = "Serious recurrent bacterial infections are a major cause of morbidity and mortality in children infected with the human immunodeficiency virus (HIV). Because intravenous immune globulin has been shown to prevent bacterial infection in patients with primary immunodeficiency and in uncontrolled studies of HIV-infected children, we undertook a multicenter study of its safety and efficacy in children with symptomatic HIV infection. In a double-blind trial, 372 HIV-infected children (mean age, 40 months) with clinical or immunologic evidence of HIV disease were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) or placebo (0.1 percent albumin) every 28 days. The children were stratified into two groups according to CD4+ lymphocyte count at entry into the study and the clinical classification of the Centers for Disease Control. The median length of follow-up was 17 months. For children in either group with CD4+ counts ≥0.2×109 per liter (≥200 per cubic millimeter) at entry, treatment with intravenous immune globulin significantly increased the time free from serious infection; estimated infection-free rates after 24 months were 67 percent for children receiving immune globulin as compared with 48 percent for those receiving placebo (P = 0.01 ). In addition, immune globulin was associated with an overall reduction in the number of both serious and minor bacterial infections (relative risk, 0.68; P = 0.01) and in the number of hospitalizations for acute care (relative risk, 0.65; P = 0.03). No such benefits were seen for children with CD4+ counts below 0.2×109 per liter at entry. For group 1 overall, there was a trend toward a difference in serious bacterial infection between immune globulin and placebo (24-month infection-free survival, 31 percent for intravenous immune globulin vs. 25 percent for placebo; P = 0.10). For group 2, the estimates of survival without serious infection were 73 percent with intravenous immune globulin as compared with 53 percent with placebo (P = 0.04). There was no effect of treatment on mortality for any group or CD4+ count at entry. Adverse reactions, noted for less than 1 percent of infusions, were minor. In symptomatic HIV-infected children the prophylactic use of intravenous immune globulin is safe, and it significantly increases the time free from serious bacterial infections for those entering treatment with CD4+ lymphocyte counts ≥0.2×109 per liter. (N Engl J Med 1991; 325:73–80.)",
author = "{The National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group} and A. Willoughby and Mofenson, {L. M.} and R. Nugent and J. Moye and Berendes, {H. W.} and Rigau-Perez, {J. G.} and S. Durako and C. Jordan and K. Rust and R. Hirschhorn and J. Bethel and K. Shah and J. Chow and P. Edelson and D. Sanders and V. Bonagura and D. Valacer and W. Henley and M. Bamji and A. Gupta and Li, {K. I.} and Abrams, {J. E.} and S. Fikrig and Bakshi, {S. S.} and Pahwa, {Savita G} and K. Krasinski and J. Pitt and L. Bernstein and A. Rubinstein and G. Johnson and Cooper, {E. R.} and L. Frenkel and Lischner, {H. W.} and Raphael, {S. A.} and Johnson, {J. P.} and T. Rakusan and S. Nesheim and A. Nahmias and H. Keyserling and R. Yogev and E. Chadwick and K. Rich and Shearer, {W. T.} and Guerra-Hanson, {I. C.} and A. Petru and C. Diaz and {Colon Santini}, {J. L.} and E. Jimenez and D. GarciaTrias and C. Acantilado",
year = "1991",
month = "7",
day = "11",
doi = "10.1056/NEJM199107113250201",
language = "English (US)",
volume = "325",
pages = "73--80",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "2",

}

TY - JOUR

T1 - Intravenous Immune Globulin for the Prevention of Bacterial Infections in Children with Symptomatic Human Immunodeficiency Virus Infection

AU - The National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group

AU - Willoughby, A.

AU - Mofenson, L. M.

AU - Nugent, R.

AU - Moye, J.

AU - Berendes, H. W.

AU - Rigau-Perez, J. G.

AU - Durako, S.

AU - Jordan, C.

AU - Rust, K.

AU - Hirschhorn, R.

AU - Bethel, J.

AU - Shah, K.

AU - Chow, J.

AU - Edelson, P.

AU - Sanders, D.

AU - Bonagura, V.

AU - Valacer, D.

AU - Henley, W.

AU - Bamji, M.

AU - Gupta, A.

AU - Li, K. I.

AU - Abrams, J. E.

AU - Fikrig, S.

AU - Bakshi, S. S.

AU - Pahwa, Savita G

AU - Krasinski, K.

AU - Pitt, J.

AU - Bernstein, L.

AU - Rubinstein, A.

AU - Johnson, G.

AU - Cooper, E. R.

AU - Frenkel, L.

AU - Lischner, H. W.

AU - Raphael, S. A.

AU - Johnson, J. P.

AU - Rakusan, T.

AU - Nesheim, S.

AU - Nahmias, A.

AU - Keyserling, H.

AU - Yogev, R.

AU - Chadwick, E.

AU - Rich, K.

AU - Shearer, W. T.

AU - Guerra-Hanson, I. C.

AU - Petru, A.

AU - Diaz, C.

AU - Colon Santini, J. L.

AU - Jimenez, E.

AU - GarciaTrias, D.

AU - Acantilado, C.

PY - 1991/7/11

Y1 - 1991/7/11

N2 - Serious recurrent bacterial infections are a major cause of morbidity and mortality in children infected with the human immunodeficiency virus (HIV). Because intravenous immune globulin has been shown to prevent bacterial infection in patients with primary immunodeficiency and in uncontrolled studies of HIV-infected children, we undertook a multicenter study of its safety and efficacy in children with symptomatic HIV infection. In a double-blind trial, 372 HIV-infected children (mean age, 40 months) with clinical or immunologic evidence of HIV disease were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) or placebo (0.1 percent albumin) every 28 days. The children were stratified into two groups according to CD4+ lymphocyte count at entry into the study and the clinical classification of the Centers for Disease Control. The median length of follow-up was 17 months. For children in either group with CD4+ counts ≥0.2×109 per liter (≥200 per cubic millimeter) at entry, treatment with intravenous immune globulin significantly increased the time free from serious infection; estimated infection-free rates after 24 months were 67 percent for children receiving immune globulin as compared with 48 percent for those receiving placebo (P = 0.01 ). In addition, immune globulin was associated with an overall reduction in the number of both serious and minor bacterial infections (relative risk, 0.68; P = 0.01) and in the number of hospitalizations for acute care (relative risk, 0.65; P = 0.03). No such benefits were seen for children with CD4+ counts below 0.2×109 per liter at entry. For group 1 overall, there was a trend toward a difference in serious bacterial infection between immune globulin and placebo (24-month infection-free survival, 31 percent for intravenous immune globulin vs. 25 percent for placebo; P = 0.10). For group 2, the estimates of survival without serious infection were 73 percent with intravenous immune globulin as compared with 53 percent with placebo (P = 0.04). There was no effect of treatment on mortality for any group or CD4+ count at entry. Adverse reactions, noted for less than 1 percent of infusions, were minor. In symptomatic HIV-infected children the prophylactic use of intravenous immune globulin is safe, and it significantly increases the time free from serious bacterial infections for those entering treatment with CD4+ lymphocyte counts ≥0.2×109 per liter. (N Engl J Med 1991; 325:73–80.)

AB - Serious recurrent bacterial infections are a major cause of morbidity and mortality in children infected with the human immunodeficiency virus (HIV). Because intravenous immune globulin has been shown to prevent bacterial infection in patients with primary immunodeficiency and in uncontrolled studies of HIV-infected children, we undertook a multicenter study of its safety and efficacy in children with symptomatic HIV infection. In a double-blind trial, 372 HIV-infected children (mean age, 40 months) with clinical or immunologic evidence of HIV disease were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) or placebo (0.1 percent albumin) every 28 days. The children were stratified into two groups according to CD4+ lymphocyte count at entry into the study and the clinical classification of the Centers for Disease Control. The median length of follow-up was 17 months. For children in either group with CD4+ counts ≥0.2×109 per liter (≥200 per cubic millimeter) at entry, treatment with intravenous immune globulin significantly increased the time free from serious infection; estimated infection-free rates after 24 months were 67 percent for children receiving immune globulin as compared with 48 percent for those receiving placebo (P = 0.01 ). In addition, immune globulin was associated with an overall reduction in the number of both serious and minor bacterial infections (relative risk, 0.68; P = 0.01) and in the number of hospitalizations for acute care (relative risk, 0.65; P = 0.03). No such benefits were seen for children with CD4+ counts below 0.2×109 per liter at entry. For group 1 overall, there was a trend toward a difference in serious bacterial infection between immune globulin and placebo (24-month infection-free survival, 31 percent for intravenous immune globulin vs. 25 percent for placebo; P = 0.10). For group 2, the estimates of survival without serious infection were 73 percent with intravenous immune globulin as compared with 53 percent with placebo (P = 0.04). There was no effect of treatment on mortality for any group or CD4+ count at entry. Adverse reactions, noted for less than 1 percent of infusions, were minor. In symptomatic HIV-infected children the prophylactic use of intravenous immune globulin is safe, and it significantly increases the time free from serious bacterial infections for those entering treatment with CD4+ lymphocyte counts ≥0.2×109 per liter. (N Engl J Med 1991; 325:73–80.)

UR - http://www.scopus.com/inward/record.url?scp=0025740950&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0025740950&partnerID=8YFLogxK

U2 - 10.1056/NEJM199107113250201

DO - 10.1056/NEJM199107113250201

M3 - Article

C2 - 1675763

AN - SCOPUS:0025740950

VL - 325

SP - 73

EP - 80

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 2

ER -