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A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection

A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection
A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection
BACKGROUND: Serious bacterial infections are common in children infected with the human immunodeficiency virus (HIV). Studies performed before zidovudine became standard therapy found that intravenous immune globulin decreases the number of serious bacterial infections in these children. We designed a multicenter study to evaluate the efficacy of intravenous immune globulin in children with advanced HIV infection who were receiving zidovudine.

METHODS: In a double-blind trial 255 children between 3 months and 12 years of age who had the acquired immunodeficiency syndrome (AIDS) or AIDS-related complex were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) (n = 129) or placebo (0.1 percent albumin) (n = 126) every 28 days. All children received 180 mg of zidovudine per square meter of body-surface area orally four times daily. Treatment assignment was stratified according to whether the patients had a history of one or more serious bacterial infections, had previously been treated with zidovudine, or were currently receiving prophylaxis with trimethoprim-sulfamethoxazole. The median length of follow-up was 30.6 months.

RESULTS: The estimated two-year rates of serious bacterial infections with confirmed pathogens were 16.9 percent for the immune globulin group and 24.3 percent for the placebo group (relative risk, 0.60; 95 percent confidence interval, 0.35 to 1.04; P = 0.07). The treatment effect was seen primarily among the 174 children who were not receiving trimethoprim-sulfamethoxazole prophylaxis at entry; the estimated two-year rates of infection were 11.3 percent for the immune globulin group and 26.8 percent for the placebo group (relative risk, 0.45; 95 percent confidence interval, 0.22 to 0.91; P = 0.03). For the 81 children who were receiving trimethoprim-sulfamethoxazole prophylaxis initially, the rates were 27.7 percent in the immune globulin group and 17.7 percent in the placebo group (relative risk, 1.26; 95 percent confidence interval, 0.44 to 3.66; P = 0.67). The two-year survival was similar in the two groups: 79.2 percent among immune globulin recipients and 75.4 percent among placebo recipients (P = 0.41).

CONCLUSIONS: In children with advanced HIV disease who are receiving zidovudine, intravenous immune globulin decreases the risk of serious bacterial infections. However, this benefit is apparent only in children who are not receiving trimethoprim-sulfamethoxazole as prophylaxis.
1181-1187
Spector, S.
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Gelber, R.
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McGrath, N.
b75c0232-24ec-443f-93a9-69e9e12dc961
Wara, D.
06135861-6fa9-4845-8beb-7c87cd507841
Barzilai, A.
1e99533d-ebe6-4ae6-98ff-4e0c5679b560
Abrams, E.
3f02d3d5-87e9-4482-b3c8-f5ea69b3573b
Bryson, Y.
002ab442-b8fc-4366-b549-74e49d37a3b8
Dankner, W.
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Livingston, R.
cc2200bf-26cb-4a0d-9273-4d37355d9553
Connor, E.
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the Pediatric AIDS Clinical Trials Group, None
6f7d55a0-e88b-4399-befb-161199bf8180
Spector, S.
6b964b6e-aaf2-4146-bb1b-46238d52d0a6
Gelber, R.
544720ad-fa9c-4813-bca2-b25340a62727
McGrath, N.
b75c0232-24ec-443f-93a9-69e9e12dc961
Wara, D.
06135861-6fa9-4845-8beb-7c87cd507841
Barzilai, A.
1e99533d-ebe6-4ae6-98ff-4e0c5679b560
Abrams, E.
3f02d3d5-87e9-4482-b3c8-f5ea69b3573b
Bryson, Y.
002ab442-b8fc-4366-b549-74e49d37a3b8
Dankner, W.
38484ae3-de28-4ea9-b3d4-17fc7d57043e
Livingston, R.
cc2200bf-26cb-4a0d-9273-4d37355d9553
Connor, E.
6f2bbfcb-0a9c-42a5-bdea-0f0524f21df1
the Pediatric AIDS Clinical Trials Group, None
6f7d55a0-e88b-4399-befb-161199bf8180

Spector, S., Gelber, R., McGrath, N., Wara, D., Barzilai, A., Abrams, E., Bryson, Y., Dankner, W., Livingston, R., Connor, E. and the Pediatric AIDS Clinical Trials Group, None (1994) A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. New England Journal of Medicine, 331 (18), 1181-1187. (doi:10.1056/NEJM199411033311802). (PMID:7935655)

Record type: Article

Abstract

BACKGROUND: Serious bacterial infections are common in children infected with the human immunodeficiency virus (HIV). Studies performed before zidovudine became standard therapy found that intravenous immune globulin decreases the number of serious bacterial infections in these children. We designed a multicenter study to evaluate the efficacy of intravenous immune globulin in children with advanced HIV infection who were receiving zidovudine.

METHODS: In a double-blind trial 255 children between 3 months and 12 years of age who had the acquired immunodeficiency syndrome (AIDS) or AIDS-related complex were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) (n = 129) or placebo (0.1 percent albumin) (n = 126) every 28 days. All children received 180 mg of zidovudine per square meter of body-surface area orally four times daily. Treatment assignment was stratified according to whether the patients had a history of one or more serious bacterial infections, had previously been treated with zidovudine, or were currently receiving prophylaxis with trimethoprim-sulfamethoxazole. The median length of follow-up was 30.6 months.

RESULTS: The estimated two-year rates of serious bacterial infections with confirmed pathogens were 16.9 percent for the immune globulin group and 24.3 percent for the placebo group (relative risk, 0.60; 95 percent confidence interval, 0.35 to 1.04; P = 0.07). The treatment effect was seen primarily among the 174 children who were not receiving trimethoprim-sulfamethoxazole prophylaxis at entry; the estimated two-year rates of infection were 11.3 percent for the immune globulin group and 26.8 percent for the placebo group (relative risk, 0.45; 95 percent confidence interval, 0.22 to 0.91; P = 0.03). For the 81 children who were receiving trimethoprim-sulfamethoxazole prophylaxis initially, the rates were 27.7 percent in the immune globulin group and 17.7 percent in the placebo group (relative risk, 1.26; 95 percent confidence interval, 0.44 to 3.66; P = 0.67). The two-year survival was similar in the two groups: 79.2 percent among immune globulin recipients and 75.4 percent among placebo recipients (P = 0.41).

CONCLUSIONS: In children with advanced HIV disease who are receiving zidovudine, intravenous immune globulin decreases the risk of serious bacterial infections. However, this benefit is apparent only in children who are not receiving trimethoprim-sulfamethoxazole as prophylaxis.

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Published date: 3 November 1994
Organisations: Primary Care & Population Sciences, Faculty of Social, Human and Mathematical Sciences

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Local EPrints ID: 350552
URI: https://eprints.soton.ac.uk/id/eprint/350552
PURE UUID: 09436cf1-db45-4c04-b69e-98fcf3d8cfff
ORCID for N. McGrath: ORCID iD orcid.org/0000-0002-1039-0159

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Date deposited: 26 Mar 2013 15:03
Last modified: 24 May 2019 00:31

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Contributors

Author: S. Spector
Author: R. Gelber
Author: N. McGrath ORCID iD
Author: D. Wara
Author: A. Barzilai
Author: E. Abrams
Author: Y. Bryson
Author: W. Dankner
Author: R. Livingston
Author: E. Connor
Author: None the Pediatric AIDS Clinical Trials Group

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