Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group.
The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (Vd) in women were 15 days and 72 mL/kg, respectively, after one and 32 days and 154 mL/kg after three monthly infusions, with stable 4 mL/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, Vd, and clearance were 30 days, 143 mL/kg, and 4 mL/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations.
Lambert
J S
JS
Institute of Human Virology, University of Maryland, Baltimore 21201, USA.
Mofenson
L M
LM
Fletcher
C V
CV
Moye
J
J
Stiehm
E R
ER
Meyer
W A
WA
Nemo
G J
GJ
Mathieson
B J
BJ
Hirsch
G
G
Sapan
C V
CV
Cummins
L M
LM
Jimenez
E
E
O'Neill
E
E
Kovacs
A
A
Stek
A
A
D000293:Adolescent; D000328:Adult; D005260:Female; D015483:HIV Antibodies / Q000032:analysis; D016655:HIV Core Protein p24 / Q000032:analysis / Q000097:blood; D015658:HIV Infections / Q000097:blood / Q000517:prevention & control* / Q000628:therapy*; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D011247:Pregnancy; D012367:RNA, Viral / Q000032:analysis / Q000097:blood
D015483:HIV Antibodies; D016655:HIV Core Protein p24; C084715:HIV hyperimmune globulin; D016756:Immunoglobulins, Intravenous; D012367:RNA, Viral