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Prophylactic Intravenous Immunoglobulin in HIV-Infected Children With CD4+ Counts of 0.20x109/L or MoreEffect on Viral, Opportunistic, and Bacterial Infections
Lynne M. Mofenson, MD;
John Moye, Jr, MD;
James Bethel, PhD;
Ronald Hirschhorn;
Carol Jordan, MSN;
Robert Nugent, PhD;
the National Institute of Child Health and Human Development Intravenous Immunoglobulin Clinical Trial Study Group;
Anne Willoughby, MD, MPH;
Lynne M. Mofenson, MD;
Robert Nugent, PhD;
John Moye, Jr, MD;
Heinz W. Berendes, MD, MHS;
Jose G. Rigau-Perez, erez MD, MPH;
Steven Durako;
Carol Jordan, RN;
Keith Rust, PhD;
Ronald Hirschhorn, MA;
James Bethel, PhD;
Kiran Shah, MD;
Jean Chow, MD;
Paul Edelson, MD;
Deborah Sanders, MD;
Vincent Bonagura, MD;
David Valacer, MD;
Walter Henley, MD;
Mahrukh Bamji, MD;
Asha Gupta, MD;
Karl I. Li, MD;
Elaine J. Abrams, MD;
Senih Fikrig, MD;
Saroj S. Bakshi, MD;
Savita Pahwa, MD;
Keith Krasinski, MD;
Jane Pitt, MD;
Larry Bernstein, MD;
Ayre Rubinstein, MD;
George Johnson, MD;
Ellen R. Cooper, MD;
Lawrence Frenkel, MD;
Harold W. Lischner, MD;
Stephen A. Raphael, MD;
John P. Johnson, MD;
Tamara Rakusan, MD;
Steven Nesheim, MD;
Andre Nahmias, MD;
Harry Keyserling, MD;
Ram Yogev, MD;
Ellen Chadwick, MD;
Kenneth Rich, MD;
William T. Shearer, MD, PhD;
I. Celine Guerra-Hanson, MD;
Ann Petru, MD;
Clemente Diaz, MD;
Juan Luis Colon Santini, MD;
Eleanore Jimenez, MD;
David Garcia-Trias, MD;
Carmen Acantilado, MD;
Richard Schwartz, MD
JAMA. 1992;268(4):483-488.
Abstract
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Objective.
—To evaluate the efficacy of intravenous immunoglobulin (IVIG) for prevention of viral, opportunistic, and minor bacterial infections in children infected with human immunodeficiency virus (HIV).
Design.
—Randomized, double-blind, placebo-controlled, outpatient clinical trial comparing subjects treated with 400 mg of IVIG per kilogram of body weight every 28 days with those given albumin placebo.
Setting.
—Twenty-eight clinical centers in mainland United States and Puerto Rico.
Patients.
—Three hundred seventy-six children infected with human immunodeficiency virus with clinical or immunologic evidence of HIV disease, 313 of whom had entry CD4+ counts of at least 0.20x109/L ( 200/mm3).
Main Outcome Measures.
—The incidence of laboratory-proven and clinically diagnosed viral, opportunistic, and bacterial infections.
Main Results.
—Viral infections and minor bacterial infections contributed more frequently to morbidity in children with entry CD4+ counts of at least 0.20x109/L (together over five times as frequent) than did serious bacterial infection, the primary outcome measure of the trial. Opportunistic infections occurred at a similar rate as laboratory-proven serious bacterial infections. In this group of children, IVIG was significantly associated with a decrease in the rate of viral infections and minor bacterial infections per 100 patient-years (36.0 vs 54.0 episodes of viral infection per 100 patient-years, IVIG vs placebo,P=.01; and 115.1 vs 159.7 episodes of minor bacterial infection per 100 patient-years, IVIG vs placebo,P-.02), as well as a decrease in the rate of serious bacterial infections per 100 patient-years (26.4 vs 48.2 episodes per 100 patient-years;P=.002). There was no apparent difference in the rate of opportunistic infections between treatment arms.
Conclusions.
—Beneficial effect of IVIG was seen across multiple infectious outcome measures, with reductions in serious and minor viral and bacterial infections observed in children with entry CD4+ counts of at least 0.20x109/L.
(JAMA. 1992;268:483-488)
Author Affiliations
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From the Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research on Mothers and Children, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md (Drs Mofenson, Moye, and Nugent); and Westat Incorporated, Rockville, Md (Dr Bethel, Mr Hirschhorn, and Ms Jordan).
National Institute of Child Health and Human Development, Pediatrie, Adolescent, and Maternal AIDS Branch, Rockville, Md; National Institute of Child Health and Human Development, Division of Prevention Research, Bethesda, Md; Westat Incorporated, Rockville, Md; Lincoln Hospital Center, Bronx, NY; Cornell Medical Center, New York (NY) Hospital; Schneider Children's Hospital, Queens Hospital Center of Long Island Jewish Medical Center, New Hyde Park, NY; Beth Israel Medical Center, New York, NY; Metropolitan Hospital Center, New York, NY; New York Medical College, Valhalla; Harlem Hospital Center, New York, NY; State University of New York Health Science Center, Brooklyn; St. Luke's/Roosevelt Hospital Center, New York, NY; North Shore University Hospital, Manhasset, NY; New York (NY) University Medicai Center—Bellevue Hospital Center; Babies Hospital, New York, NY; Albert Einstein College of Medicine, Bronx, NY; University of Connecticut Health Center, Hartford; Boston (Mass) City Hospital; University of Medicine and Dentistry of New Jersey—Robert Wood Johnson Medical School, New Brunswick, NJ; St Christopher's Hospital for Children, Philadelphia, Pa; University of Maryland, Baltimore, Md; Children's Hospital National Medical Center, Washington, DC; Emory University School of Medicine, Atlanta, Ga; The Children's Memorial Hospital, Chicago, Ill; University of Illinois at Chicago College of Medicine; Texas Children's Hospital, Houston; Children's Hospital Medical Center, Oakland, Calif; University of Puerto Rico, San Juan; San Juan City Hospital, Puerto Rico; Ramon Ruiz Arnau University Hospital, Bayamon, Puerto Rico; Cutter Biological, Miles Laboratories Inc, Berkeley, Calif
Footnotes
Members of the National Institute of Child Health and Human Development Intravenous Immunoglobulin Clinical Trial Study Group are listed at the end of this article.
Reprint requests to Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research on Mothers and Children, National Institute of Child Health and Human Development, National Institutes of Health, 6120 Executive Blvd, Room 450, Bethesda, MD 20892 (Dr Mofenson).
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