Developing an Adaptive Trial Design that Accounts for Rapidly Changing Pediatric Physiology

Mother-to-child HIV transmission (MTCT) is a public health issue in low-resource countries. Prophylactic treatment of newborns shortly after birth is critical to prevent MTCT. Raltegravir is an antiretroviral agent which blocks a critical step in the virus lifecycle―integration of viral DNA into the host cell. Currently, this drug is only approved for treating infants at least 4 weeks old.

In this webinar, we discussed a population pharmacokinetic modeling and simulation approach to design a raltegravir dosing regimen for the prevention or treatment of HIV in newborns up to 6 weeks of age.