Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.

ABSTRACT:

Background

Data describing the pharmacokinetics and safety of tenofovir in neonates are lacking.

Methods

The HIV Prevention Trials Network 057 protocol was a phase 1, open-label study of the pharmacokinetics and safety of tenofovir disoproxil fumarate (TDF) in HIV-infected women during labor and their infants during the first week of life with 4 dosing cohorts: maternal 600 mg doses/no infant dosing; no maternal dosing/infant 4 mg/kg doses on days 0, 3, and 5; maternal 900 mg doses/infant 6 mg/kg doses on days 0, 3, and 5; maternal 600 mg doses/infant 6 mg/kg daily for 7 doses. Pharmacokinetic sampling was performed on cohort 1 and 3 mothers and all infants. Plasma, amniotic fluid, and breast milk tenofovir concentrations were determined by liquid chromatographic-tandem mass

SUBMITTER: Mirochnick M 

PROVIDER: S-EPMC3912736 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature