Randomized controlled trial of short-term withdrawal of i.v. immunoglobulin therapy for selected children with human immunodeficiency virus infection.
BACKGROUND
The aim of the present paper was to determine whether monthly i.v. immunoglobulin (IVIG) could be safely discontinued in antiretroviral-treated human immunodeficiency virus (HIV)-infected children.


METHODS
In a double-blind cross-over trial, children < or =18 years with HIV infection, well controlled on antiretroviral therapy, were randomized to alternating courses of 3 consecutive months of IVIG (400 mg/kg once a month) and 3 consecutive months of placebo for 1 year. The primary outcome was days of fever per month. Secondary outcomes were frequency of serious infections, changes in HIV viral load (VL), CD4+ counts and IgG levels.


RESULTS
Fifteen children were enrolled. Using the revised pediatric HIV clinical classification system of the Centers for Disease Control and Prevention, eight were severely symptomatic (C), four were moderately symptomatic (B) and three were mildly symptomatic (A). There were no statistically significant outcome measures. The mean number of days of fever per month with IVIG versus placebo was 0.55 days versus 1.48 days (P = 0.11). The difference was 0.9 days (95% confidence interval: +2.05 to -0.25). There were no serious infections in either period. For the IVIG versus placebo periods, mean CD4 counts were 970 cells/microL versus 906 cells/microL (P = 0.12), VL 2.90 log(10) copies/mL versus 2.82 log(10) copies/mL (P = 0.70) and IgG levels were 17.41 g/L versus 16.6 g/L (P = 0.13).


CONCLUSIONS
In antiretroviral-treated HIV-infected children short-term withdrawal of monthly IVIG was not associated with a significant increase in incidence of infections or a decline in immunologic function (CD4 count, viral load and IgG levels). These results suggest that monthly IVIG can be safely discontinued in HIV-infected children who are clinically stable and receiving combination antiretroviral therapy.
Department of Pediatrics, Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada.
Galia
G
Grisaru-Soen
Wendy
W
Lau
Cheryl
C
Arneson
Deborah
D
Louch
Ari
A
Bitnun
Derek
D
Stephens
Stanley E
SE
Read
Susan M
SM
King
D017088:AIDS-Related Opportunistic Infections / Q000453:epidemiology; D000293:Adolescent; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000209:etiology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage*; D007155:Immunologic Factors / Q000008:administration & dosage*; D008297:Male
D044966:Anti-Retroviral Agents; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors