St. Jude Children’s Research Hospital in Memphis, Tenn., is leading two clinical trials aimed at expanding HIV treatment and prevention options for the youngest pediatric populations.
The hospital was the first site globally to enroll patients in both IMPAACT 2036 — a study evaluating long-acting injectable antiretrovirals in children ages 2 to 11 — and GS5578, which is testing a fixed-dose HIV prevention regimen in newborns. The two trials are part of broader efforts to bring adult-approved HIV medications to younger age groups through age-appropriate formulations and dosing.
GS5578 is the first study to test a combination of bictegravir, emtricitabine and tenofovir alafenamide in newborns. The formulation, dissolved in liquid and given via oral syringe, offers a simpler alternative to current options that require administering three separate medications twice daily. Infants in the trial receive two doses within the first two weeks of life and are followed for eight weeks.
IMPAACT 2036 builds on the 2021 FDA approval of long-acting injectable HIV therapy for adults and subsequent adolescent trials. The new study assesses cabotegravir and rilpivirine in children under 12, with a focus on dosage, safety and tolerability.
Researchers said the goal is to reduce the burden of daily medication, improve adherence and offer families more flexibility. “We’ve heard how much adults’ lives improve with injectable options — now we want to offer that same quality-of-life improvement to kids,” said Susan Carr, PharmD, a clinical pharmacist at St. Jude.
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