NIH-funded research P01 program project

Drug, gut microbiome, and immune factors shaping birth and brain development in HIV-exposed but uninfected children

Official title: Drug, microbiome, and immune determinants of birth and neurodevelopmental outcomes in children with exposure to HIV infection

Funded at University of Washington · NIH-11408459 · Data updated 2026-11-12

This project will follow HIV-exposed but uninfected children to understand how maternal treatment, gut microbes, breastmilk sugars, and immune factors influence growth and brain development.

More HIV Infection research and trials

Quick facts

Grant typeP01 program project
Study typeNIH-funded research
Funding institutionUniversity of Washington
NIH-funded
Lab location1 site (Seattle, United States)
Project startSeptember 4, 2025
Project endAugust 31, 2027
Funding year2026
Award (this year)$1,506,383
NIH project number5P01HD107669-03
Project IDNIH-11408459 on NIH RePORTER

Who could benefit from this research

Could help

Pregnant people living with HIV and their uninfected newborns, plus a comparison group of HIV-unexposed infants.

Less likely to help

Children without exposure to HIV or without the specific maternal treatment or immune factors studied are less likely to benefit directly.

What this research studies

Researchers will track three linked projects using shared measurements to study how maternal dolutegravir use and viral load, the infant microbiome and breastmilk HMOs, and maternal/infant immune activation and CMV affect growth and neurodevelopment in HEU children and HIV-unexposed peers. Standardized neurodevelopment assessments and harmonized analyses will be used across three birth cohorts. The study aims to uncover mechanisms behind early developmental differences and inform safer maternal treatment and infant care. Results could guide clinical decisions and interventions to optimize outcomes for HEU children.

Why it matters

Potential benefit: If successful, findings could improve guidelines for HIV management during pregnancy and lead to strategies that support growth and brain development in HEU children.

How similar studies have gone: Prior birth cohort studies have shown links between gut microbiome and neurodevelopment, but this program adds integrated multi-cohort analysis and maternal regimen effects.

Where this research is happening

  • University of Washington
    Seattle, United States
    Active

Researchers

  • Principal investigator: John-Stewart, Grace C. — University of Washington
  • Study coordinator: John-Stewart, Grace C.

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.