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An international study conducted through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, including researchers at the University of California San Diego, helped inform the U.S. Food and Drug Administration's (FDA) recent approval of dolutegravir, a second-generation integrase inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in newborns from birth. The study, published in The Lancet HIV, identified a dosing regimen that achieves appropriate drug levels in full-term newborns, supporting the use of dolutegravir to treat HIV from the first days of life.

Previously, dolutegravir was approved only for adults and children aged 4 weeks and older. The new findings help establish an appropriate dosing regimen for use beginning at birth, expanding access to an antiretroviral medication widely used to treat HIV in older children and adults.

"Newborns process medications differently than older children and adults, and their ability to eliminate drugs changes rapidly during the first month of life," said Jeremiah Momper, Pharm.D., Ph.D., first author on the study and professor at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. "Our study provides important pharmacokinetic and safety data to guide dolutegravir dosing during this critical period of development."

The study, known as IMPAACT 2023, was a phase 1 clinical trial conducted across sites in South Africa, Thailand and the United States, led by researchers at Boston Medical Center (BMC).

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