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M94A0225.TXT
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1994-10-08
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Document 0225
DOCN M94A0225
TI Crossover of placebo patients to intravenous immunoglobulin confirms
efficacy for prophylaxis of bacterial infections and reduction of
hospitalizations in human immunodeficiency virus-infected children. The
National Institute of Child Health and Human Development Intravenous
Immunoglobulin Clinical Trial Study Group.
DT 9412
AU Mofenson LM; Moye J Jr; Korelitz J; Bethel J; Hirschhorn R; Nugent R;
Pediatric, Adolescent and Maternal AIDS Branch, National; Institute of
Child Health and Human Development, National; Institutes of Health,
Rockville, MD 20852.
SO Pediatr Infect Dis J. 1994 Jun;13(6):477-84. Unique Identifier :
AIDSLINE MED/94359769
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.(ABSTRACT TRUNCATED AT
250 WORDS)
DE AIDS-Related Opportunistic Infections/*PREVENTION & CONTROL Bacterial
Infections/*PREVENTION & CONTROL Child Child, Preschool Double-Blind
Method Female Follow-Up Studies Hospitalization/STATISTICS & NUMER
DATA Human HIV Infections/THERAPY Immunoglobulins,
Intravenous/*THERAPEUTIC USE Male Pneumonia, Pneumocystis carinii/DRUG
THERAPY/*PREVENTION & CONTROL Time Factors Treatment Outcome
Trimethoprim-Sulfamethoxazole Combination/*THERAPEUTIC USE
Zidovudine/THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED
CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).