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IMPAACT P1115 Team Publishes Two-Year Findings for Newborns Who Received Very Early Treatment for HIV


Findings published in Lancet HIV from IMPAACT P1115 showed that for newborns with HIV, starting treatment within 48 hours of birth is feasible and safe. Findings may also provide clues toward achieving HIV remission or cure for children with HIV. 

Babies born with HIV have limited treatment options, as HIV medications approved for newborns can be challenging to give consistently, usually once or twice per day. Despite these difficulties, most babies who received very early treatment in the study achieved a low HIV viral load by six months of age. A smaller number of babies in the study achieved an undetectable viral load, with no HIV found in their blood, through two years of age.  

As the study continues, investigators will learn more about babies who received very early treatment. Current findings indicate that very early treatment limits the buildup of HIV reservoirs. For some babies, this may help make remission achievable. Remission means having no HIV detectable in blood tests after treatment is stopped. 

The IMPAACT Network congratulates the P1115 protocol team and study sites for their excellent work conducting the study and publishing critical new data on very early treatment. Study sites are commended for their efforts in engaging with communities and participant families, and families are gratefully acknowledged for their time and dedication, without which the study would not be possible. The Network remains committed to ongoing and future research to identify more child-friendly HIV medications, especially for newborns and young babies, and to find a cure for children with HIV.  

newborn hand with hospital wristband
IMPAACT P1115 is a Phase I/II, multi-center, proof-of-concept study that will explore the effects of early intensive antiretroviral therapy on achieving HIV remission in neonates. The study will also assess the safety and pharmacokinetics of early intensive antiretroviral therapy in neonates.

Read the Full Publication

Title: HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study

Authors: Deborah Persaud, MD; Yvonne Bryson, MD; Bryan S Nelson, SM; Camlin Tierney, PhD; Mark F Cotton, PhD; Anne Coletti, MS; Jennifer Jao, MD; Stephen A Spector, MD; Mark Mirochnick, MD; Edmund V Capparelli, PharmD; Diane Costello, BS; Joseph Szewczyk, BS; Nicol Nicodimus, BSc; Lynda Stranix-Chibanda, MBChB; Adeodata R Kekitiinwa, MMed; Violet Korutaro, MBChB; Christina Reding, MPH; Mary N Carrington, PhD; Sai Majji, PhD; Dwight E Yin, MD; Patrick Jean-Philippe, MD; Ellen G Chadwick, MD.

Published: December 04, 2023