This is a placebo controlled randomized clinical trial which will test the hypothesis that intravenous immunoglobulin (IVIG) administered every 28 days, in comparison to an intravenous placebo, will significantly reduce the rate of serious, like threatening bacterial infections and/or deaths in symptomatic children who are infected with the human immunodeficiency virus (HIV). Eligible HIV infected non-hemophiliac children less than 13 years of age are being assigned to one of two groups on the basis of total T-4 count and clinical staging using the CDC classification system. Group I will contain those patients with more severe clinical disease. Group II will contain patients with less sever clinical illness. Patients within each group are randomly assigned to receive either IVIG or IV albumin placebo. The duration of treatment for each child who is enrolled in the clinical trial will be two years. Enrollment in the study began around March 1, 1988 and about 28 hospitals have agreed to follow the protocol. As of June 17, 1988 104 children had been recruited into this trial.

Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
1988
Total Cost
Indirect Cost
Name
U.S. National Inst/Child Hlth/Human Dev
Department
Type
DUNS #
City
State
Country
United States
Zip Code