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, L. M. Mofenson, R. Nugent, J. Moye, H. W. Berendes, J. G. Rigau-Perez, Sumner Yaffe, K. Shah, J. Chow, P. Edelson, D. Sanders, V. Bonagura, D. Valacer, W. HenleyM. Bamji, A. Gupta, K. I. Li, E. J. Abrams, M. Frere, S. Fikrig, S. S. Bakshi, S. Pahwa, Arye Rubinstein, 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. Hirschhorn, J. Bethel, R. Schwartz

Research output: Chapter in Book/Report/Conference proceedingChapter

34 Citations (Scopus)

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)
Title of host publicationPediatric Infectious Disease
Pages477-484
Number of pages8
Volume13
Edition6
StatePublished - 1994

Fingerprint

Intravenous Immunoglobulins
Bacterial Infections
Hospitalization
Placebos
HIV
Sulfamethoxazole Drug Combination Trimethoprim
Pneumocystis Pneumonia
Confidence Intervals
Infection
Zidovudine

Keywords

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

ASJC Scopus subject areas

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

Cite this

Mofenson, L. M., Moye, J., Korelitz, J., Bethel, J., Hirschhorn, R., Nugent, R., ... 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. In Pediatric Infectious Disease (6 ed., Vol. 13, pp. 477-484)

Crossover of placebo patients to intravenous immunoglobulin confirms efficacy for prophylaxis of bacterial infections and reduction of hospitalizations in human immunodeficiency virus-infected children. / Mofenson, Lynne M.; Moye, John; Korelitz, James; Bethel, James; Hirschhorn, Ronald; Nugent, Robert; Willoughby, A.; Mofenson, L. M.; Nugent, R.; Moye, J.; Berendes, H. W.; Rigau-Perez, J. G.; Yaffe, Sumner; Shah, K.; Chow, J.; Edelson, P.; Sanders, D.; Bonagura, V.; Valacer, D.; Henley, W.; Bamji, M.; Gupta, A.; Li, K. I.; Abrams, E. J.; Frere, M.; Fikrig, S.; Bakshi, S. S.; Pahwa, S.; Rubinstein, Arye; Pitt, J.; Bernstein, L.; Rubinstein, A.; Johnson, G.; Cooper, E. R.; Frenkel, L.; Gaur, S.; Lischner, H. W.; Raphael, S. A.; Johnson, J. P.; Rakusan, T.; Nesheim, S.; Nahmias, A.; Keyserling, H.; Yogev, R.; Chadwick, E.; Rich, K.; Shearer, W. T.; Guerra-Hanson, I. C.; Petru, A.; Diaz, C.; Colon Santini, J. L.; Jimenez, E.; Garcia-Trias, D.; Acantilado, C.; Durako, S.; Jordan Nesel, C.; Rust, K.; Hirschhorn, R.; Bethel, J.; Schwartz, R.

Pediatric Infectious Disease. Vol. 13 6. ed. 1994. p. 477-484.

Research output: Chapter in Book/Report/Conference proceedingChapter

Mofenson, LM, Moye, J, Korelitz, J, Bethel, J, Hirschhorn, R, Nugent, R, Willoughby, A, Mofenson, LM, Nugent, R, Moye, J, Berendes, HW, Rigau-Perez, JG, Yaffe, S, Shah, K, Chow, J, Edelson, P, Sanders, D, Bonagura, V, Valacer, D, Henley, W, Bamji, M, Gupta, A, Li, KI, Abrams, EJ, Frere, M, Fikrig, S, Bakshi, SS, Pahwa, S, Rubinstein, A, Pitt, J, Bernstein, L, Rubinstein, A, Johnson, G, Cooper, ER, Frenkel, L, Gaur, S, Lischner, HW, Raphael, SA, Johnson, JP, Rakusan, T, Nesheim, S, Nahmias, A, Keyserling, H, Yogev, R, Chadwick, E, Rich, K, Shearer, WT, Guerra-Hanson, IC, Petru, A, Diaz, C, Colon Santini, JL, Jimenez, E, Garcia-Trias, D, Acantilado, C, Durako, S, Jordan Nesel, C, Rust, K, Hirschhorn, R, Bethel, J & 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. in Pediatric Infectious Disease. 6 edn, vol. 13, pp. 477-484.
Mofenson LM, Moye J, Korelitz J, Bethel J, Hirschhorn R, Nugent R et al. Crossover of placebo patients to intravenous immunoglobulin confirms efficacy for prophylaxis of bacterial infections and reduction of hospitalizations in human immunodeficiency virus-infected children. In Pediatric Infectious Disease. 6 ed. Vol. 13. 1994. p. 477-484
Mofenson, Lynne M. ; Moye, John ; Korelitz, James ; Bethel, James ; Hirschhorn, Ronald ; Nugent, Robert ; Willoughby, A. ; Mofenson, L. M. ; Nugent, R. ; Moye, J. ; Berendes, H. W. ; Rigau-Perez, J. G. ; Yaffe, Sumner ; Shah, K. ; Chow, J. ; Edelson, P. ; Sanders, D. ; Bonagura, V. ; Valacer, D. ; Henley, W. ; Bamji, M. ; Gupta, A. ; Li, K. I. ; Abrams, E. J. ; Frere, M. ; Fikrig, S. ; Bakshi, S. S. ; Pahwa, S. ; Rubinstein, Arye ; Pitt, J. ; Bernstein, L. ; Rubinstein, A. ; Johnson, G. ; Cooper, E. R. ; Frenkel, L. ; Gaur, S. ; Lischner, H. W. ; Raphael, S. A. ; Johnson, J. P. ; Rakusan, T. ; Nesheim, S. ; Nahmias, A. ; Keyserling, H. ; Yogev, R. ; Chadwick, E. ; Rich, K. ; Shearer, W. T. ; Guerra-Hanson, I. C. ; Petru, A. ; Diaz, C. ; Colon Santini, J. L. ; Jimenez, E. ; Garcia-Trias, D. ; Acantilado, C. ; Durako, S. ; Jordan Nesel, C. ; Rust, K. ; Hirschhorn, R. ; Bethel, J. ; Schwartz, R. / 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. Vol. 13 6. ed. 1994. pp. 477-484
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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.",
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AU - Mofenson, Lynne M.

AU - Moye, John

AU - Korelitz, James

AU - Bethel, James

AU - Hirschhorn, Ronald

AU - Nugent, Robert

AU - Willoughby, A.

AU - Mofenson, L. M.

AU - Nugent, R.

AU - Moye, J.

AU - Berendes, H. W.

AU - Rigau-Perez, J. G.

AU - Yaffe, Sumner

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, E. J.

AU - Frere, M.

AU - Fikrig, S.

AU - Bakshi, S. S.

AU - Pahwa, S.

AU - Rubinstein, Arye

AU - Pitt, J.

AU - Bernstein, L.

AU - Rubinstein, A.

AU - Johnson, G.

AU - Cooper, E. R.

AU - Frenkel, L.

AU - Gaur, S.

AU - Lischner, H. W.

AU - Raphael, S. A.

AU - Johnson, J. P.

AU - Rakusan, T.

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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 - Garcia-Trias, D.

AU - Acantilado, C.

AU - Durako, S.

AU - Jordan Nesel, C.

AU - Rust, K.

AU - Hirschhorn, R.

AU - Bethel, J.

AU - Schwartz, R.

PY - 1994

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N2 - 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.

AB - 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.

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