We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Safety and Pharmacokinetics of Hyperimmune Anti-Human Immunodeficiency Virus (HIV) Immunoglobulin Administered to HIV-Infected Pregnant Women and Their Newborns.
- Authors
Lambert, John S.; Mofenson, Lynne M.; Fletcher, Courtney V.; Moye, Jack; Stiehm, E. Richard; Meyer, William A.; Nemo, George J.; Mathieson, Bonnie J.; Hirsch, Geri; Sapan, Christine V.; Cummins, Laurence M.; Jimenez, Eleanor; O'Neill, Edward; Kovacs, Andrea; Stek, Alice
- Abstract
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.
- Publication
Journal of Infectious Diseases, 1997, Vol 175, Issue 2, p283
- ISSN
0022-1899
- Publication type
Article