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. Li; E. 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

doi:10.1097/00006454-199406000-00003

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

Pediatrics

Research output: Contribution to journal › Article › peer-review

37 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 language	English (US)
Pages (from-to)	477-484
Number of pages	8
Journal	Pediatric Infectious Disease
Volume	13
Issue number	6
DOIs	https://doi.org/10.1097/00006454-199406000-00003
State	Published - Jun 1 1994

Keywords

Infection prophylaxis
Intravenous immunoglobulin
Pediatric human immunodeficiency virus infection

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Microbiology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/00006454-199406000-00003

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

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 et al.
In: Pediatric Infectious Disease, Vol. 13, No. 6, 01.06.1994, p. 477-484.

Research output: Contribution to journal › Article › peer-review

Mofenson, LM, Moye, J, Korelitz, J, Bethel, J, Hirschhorn, R, Nugent, R, Willoughby, A, 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, Krasinski, K, 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 & 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, vol. 13, no. 6, pp. 477-484. https://doi.org/10.1097/00006454-199406000-00003

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

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.",

keywords = "Infection prophylaxis, Intravenous immunoglobulin, Pediatric human immunodeficiency virus infection",

author = "Mofenson, {Lynne M.} and John Moye and James Korelitz and James Bethel and Ronald Hirschhorn and Robert Nugent and A. Willoughby and Berendes, {H. W.} and Rigau-Perez, {J. G.} and Sumner Yaffe 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, {E. J.} and M. Frere and S. Fikrig and Bakshi, {S. S.} and S. Pahwa and K. Krasinski and J. Pitt and L. Bernstein and A. Rubinstein and G. Johnson and Cooper, {E. R.} and L. Frenkel and S. Gaur 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. Garcia-Trias and C. Acantilado and S. Durako and {Jordan Nesel}, C. and K. Rust and R. Schwartz",

year = "1994",

month = jun,

day = "1",

doi = "10.1097/00006454-199406000-00003",

language = "English (US)",

volume = "13",

pages = "477--484",

journal = "Pediatric Infectious Disease",

issn = "0891-3668",

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T1 - Crossover of placebo patients to intravenous immunoglobulin confirms efficacy for prophylaxis of bacterial infections and reduction of hospitalizations in human immunodeficiency virus-infected children

AU - Mofenson, Lynne M.

AU - Moye, John

AU - Korelitz, James

AU - Bethel, James

AU - Hirschhorn, Ronald

AU - Nugent, Robert

AU - Willoughby, A.

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 - Krasinski, K.

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.

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 - Garcia-Trias, D.

AU - Acantilado, C.

AU - Durako, S.

AU - Jordan Nesel, C.

AU - Rust, K.

AU - Schwartz, R.

PY - 1994/6/1

Y1 - 1994/6/1

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.

KW - Infection prophylaxis

KW - Intravenous immunoglobulin

KW - Pediatric human immunodeficiency virus infection

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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