Crossover of placebo patients to intravenous immunoglobulin confirms efficacy for prophylaxis of bacterial infections and reduction of hospitalizations in human immunodeficiency virus-infected children

Lynne M. Mofenson, John Moye, James Korelitz, James Bethel, Ronald Hirschhorn, Robert Nugent, A. Willoughby, H. W. Berendes, J. G. Rigau-Perez, Sumner Yaffe, K. Shah, J. Chow, P. Edelson, D. Sanders, V. Bonagura, D. Valacer, W. Henley, M. Bamji, A. Gupta, K. I. LiE. J. Abrams, M. Frere, S. Fikrig, S. S. Bakshi, S. Pahwa, K. Krasinski, J. Pitt, L. Bernstein, A. Rubinstein, G. Johnson, E. R. Cooper, L. Frenkel, S. Gaur, H. W. Lischner, S. A. Raphael, J. P. Johnson, T. Rakusan, S. Nesheim, A. Nahmias, H. Keyserling, R. Yogev, E. Chadwick, K. Rich, W. T. Shearer, I. C. Guerra-Hanson, A. Petru, C. Diaz, J. L. Colon Santini, E. Jimenez, D. Garcia-Trias, C. Acantilado, S. Durako, C. Jordan Nesel, K. Rust, R. Schwartz

Research output: Contribution to journalArticle

34 Scopus citations

Abstract

After completion of a placebo-controlled trial of intravenous immunoglobulin (IVIG) infection prophylaxis, patients were offered open label IVIG and optional participation in a follow-up study. The purpose of the follow-up study was to evaluate the IVIG effect in original placebo recipients and longevity of IVIG benefit in original IVIG recipients. Of 212 human immunodeficiency virus-infected children on study at trial closure, 148 (67 of 98 (68%) placebo and 81 of 114 (71%) IVIG patients) received open label IVIG for a mean of 16 months. When open label IVIG was begun, 45% were receiving trimethoprim-sulfamethoxazole prophylaxis for Pneumocystis carinii pneumonia (43% of placebo and 47% of IVIG patients) and 54% were receiving zidovudine (55% of placebo and 53% of IVIG patients). In patients who received placebo during the original study, the rate of serious bacterial infections was significantly lower after change to open label IVIG (estimated 15.8 fewer episodes/100 patient years; 95% confidence interval, 3.2 to 28.5; P = 0.014). Similar findings were observed for minor bacterial infections (estimated 61.2 fewer/100 patient years; 95% confidence interval, 29.2 to 93.3; P < 0.001) and hospitalizations (estimated 43.7 fewer/100 patient years; 95% confidence interval, 27.7 to 59.6; P < 0.001). Decreases were observed whether or not trimethoprim-sulfamethoxazole prophylaxis was being given at the time open label IVIG was begun. In patients who received IVIG during the original study, no significant difference was seen in infections or hospitalizations after change to open label IVIG. These results confirm IVIG effectiveness for reduction of bacterial infections and hospitalizations in human immunodeficiency virus-infected children and indicate that benefit is maintained for at least 3 years. In this patient cohort decrease in infections and hospitalizations with IVIG was independent of trimethoprim-sulfamethoxazole P. carinii pneumonia prophylaxis.

Original languageEnglish (US)
Pages (from-to)477-484
Number of pages8
JournalPediatric Infectious Disease
Volume13
Issue number6
DOIs
StatePublished - Jun 1 1994

Keywords

  • Infection prophylaxis
  • Intravenous immunoglobulin
  • Pediatric human immunodeficiency virus infection

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)

Fingerprint Dive into the research topics of 'Crossover of placebo patients to intravenous immunoglobulin confirms efficacy for prophylaxis of bacterial infections and reduction of hospitalizations in human immunodeficiency virus-infected children'. Together they form a unique fingerprint.

  • Cite this

    Mofenson, L. M., Moye, J., Korelitz, J., Bethel, J., Hirschhorn, R., Nugent, R., Willoughby, A., Berendes, H. W., Rigau-Perez, J. G., Yaffe, S., Shah, K., Chow, J., Edelson, P., Sanders, D., Bonagura, V., Valacer, D., Henley, W., Bamji, M., Gupta, A., ... Schwartz, R. (1994). Crossover of placebo patients to intravenous immunoglobulin confirms efficacy for prophylaxis of bacterial infections and reduction of hospitalizations in human immunodeficiency virus-infected children. Pediatric Infectious Disease, 13(6), 477-484. https://doi.org/10.1097/00006454-199406000-00003