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.(ABSTRACT TRUNCATED AT 250 WORDS)