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).