IMPAACT P1093 Informs U.S. FDA Decision
The IMPAACT Operations Center has announced that data from IMPAACT P1093 and the ODYSSEY (PENTA20) study have informed the United States (U.S.) Food and Drug Administration (FDA) decision to approve the first-ever dispersible tablet formulation of Tivicay PD (dolutegravir) tablets for children as young as four weeks of age and weighing at least 3 kg (or about 6.5 pounds). Prior to this approval, dolutegravir was indicated in the U.S. for children from six years of age and weighing more than 30 kg (or about 66 pounds).
IMPAACT P1093 is an ongoing pharmacokinetic (PK), safety and dose-finding study of dolutegravir in combination antiretroviral treatment regimens in infants, children, and adolescents living with HIV. The study has enrolled more than 180 children at 34 research sites in Botswana, Brazil, Kenya, South Africa, Tanzania, Thailand, Uganda, the U.S., and Zimbabwe.
Protocol Data Managers Mattie Bartlett, Stephanie Popson, and Yvonne Woolwine-Cunningham, and Laboratory Data Manager Kevin Knowles from Frontier Science work on P1093.