International study helps support FDA approval of HIV drug for newborns

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.

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