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P1097 / Raltegravir PK Study
Raltegravir Pharmacokinetics and Safety in Neonates
Study Status
Participants Off Study and Primary Analysis Completed
DAIDS Number
11790
IND Number
77,787
Clinical Trials Link
Primary Protocol Team Members
Summary
P1097 is a Phase 0, multi-center washout pharmacokinetic trial of raltegravir in infants born to HIV-infected pregnant women. The study is designed to determine the washout pharmacokinetics and safety of in utero/intrapartum exposure following the infants for up to 20 weeks after birth.
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