90015
document
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 .
90016
Intervention_Pharmacological
hyperimmune anti-human immunodeficiency virus ( HIV ) immunoglobulin
90017
Intervention_Pharmacological
hyperimmune anti-human immunodeficiency virus ( HIV ) intravenous immunoglobulin ( HIVIG )
90018
Intervention_Pharmacological
HIVIG
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Intervention_Pharmacological
HIVIG
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Outcome_Other
Safety
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Outcome_Other
pharmacokinetics
90022
Outcome_Other
pharmacokinetics
90023
Outcome_Other
safety
90024
Outcome_Physical
HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen , and plasma HIV-1 RNA levels
90025
Outcome_Adverse-effects
adverse clinical effects
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Outcome_Adverse-effects
adverse hematologic , blood chemistry , or immunologic effects
90027
Outcome_Other
well-tolerated
90028
Outcome_Other
pharmacokinetics
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Participant_Condition
HIV-infected
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Participant_Sex
women
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Participant_Sample-size
28
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Participant_Age
maternal-infant pairs
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Participant_Condition
intravenous immunoglobulin
90034
Participant_Condition
HIV
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Participant_Sex
pregnant women
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Participant_Age
their newborns