Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants
Status:
Completed
Trial end date:
2018-04-23
Target enrollment:
Participant gender:
Summary
The purpose of this study was to determine the washout pharmacokinetics (PK) and safety of in
utero/intrapartum exposure to maternal raltegravir (RAL) in infants born to pregnant women
with HIV infection who received RAL 400 mg twice daily. The study also provided data for the
development of an infant RAL starting dosing regimen for IMPAACT P1110 (NCT01780831).
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)