FDA Approves Expanded Dosing in Neonates for Raltegravir

On November 22, the U.S. Food and Drug Administration (FDA) approved updates to the label for raltegravir (also known by the brand name Isentress). This change expands the patient population to include HIV-1 exposed full term neonates from birth to four weeks of age.

Raltegravir is a potent and selective HIV-1 integrase inhibitor. It is used as a treatment for HIV/AIDS, and can also be used as part of a post exposure prophylaxis (PEP).

The change to the label was based on data from the International Material Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) study P1110. Frontier Science, along with the Harvard T.H. Chan School of Public Health, provide data management and statistical support for this study. The quote below is from the the IMPAACT announcement.


IMPAACT P1110 is an ongoing Phase I, open label, non-comparative dose-finding study of HIV-1 exposed full-term neonates assessed as at risk of acquiring HIV-1 infection and their mothers. The study is designed to evaluate the safety and tolerability of raltegravir oral granules for suspension when administered during the first 6 weeks of life with standard ARV prophylaxis for prevention of vertical HIV transmission. Expanding the limited ARV options for neonates and infants is a key priority for the IMPAACT Network, and we are pleased with the FDA announcement.

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