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P1110 / Safety and PK of RAL in Neonates

A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Infants at High Risk

DAIDS Number

11891

IND Number

77,787

Clinical Trials Link

Summary

P1110 is a Phase I, open label, non-comparative dose-finding study of HIV-1 exposed full-term neonates (aged ≤48 hours) assessed as high risk of acquiring HIV-1 infection and their mothers.  The study is designed to evaluate the safety and tolerability through 6 weeks of life of raltegravir oral granules for suspension when administered during the first 6 weeks of life with standard PMTCT ARV prophylaxis to HIV-1 exposed infants assessed at high risk of HIV infection.

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