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Previous Volume 331:1181-1187 November 3, 1994 Number 18 Next

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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.

Source Information

From the University of California, San Diego, La Jolla, Calif. (S.A.S., W.M.D.); the Harvard School of Public Health, Boston (R.D.G., N.M.); the University of California, San Francisco (D.W.); Mt. Sinai Hospital, New York (A.B.); Columbia University, New York (E.A.); UCLA, Los Angeles (Y.J.B.); Johns Hopkins University, Baltimore (R.A.L.); and the New Jersey Medical School, Newark (E.M.C.). The members of the Pediatric AIDS Clinical Trials Group who participated in this study are listed in the Appendix.

Address reprint requests to Dr. Spector at the University of California, San Diego, 9500 Gilman Dr., La Jolla, CA 92093-0672.

Full Text of this Article

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Prophylactic Immune Globulin in Children with HIV Disease
Mofenson L. M., Nugent R., Spector S. A., Gelber R. D., Wara D. W.
Extract | Full Text  
N Engl J Med 1995; 332:750-752, Mar 16, 1995. Correspondence

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