Dolutegravir use in pregnancy and infant brain development
Integrase Inhibitors during pregnancy and Neurodevelopmental Outcomes: Underlying Mechanism and Therapeutic Intervention
['FUNDING_R01'] · UNIVERSITY OF NEBRASKA MEDICAL CENTER · NIH-11320735
Looking at whether the HIV medicine dolutegravir can affect a baby's brain when taken during pregnancy and whether treatments can reduce any harm.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF NEBRASKA MEDICAL CENTER (nih funded) |
| Locations | 1 site (OMAHA, UNITED STATES) |
| Trial ID | NIH-11320735 on ClinicalTrials.gov |
What this research studies
Researchers will study how dolutegravir behaves in pregnancy and whether it reaches the fetal brain, using laboratory and animal models to trace the drug and its effects. Early lab data suggest dolutegravir can block enzymes called MMPs that help brain development, so the team will test that mechanism. They will also explore potential therapies or interventions that might protect the developing brain while keeping HIV controlled. The work aims to provide evidence that could guide safer use of dolutegravir in people who are pregnant or may become pregnant.
Who could benefit from this research
Good fit: Pregnant people with HIV or people of childbearing potential taking or considering dolutegravir are the most relevant group for related clinical follow-up or enrollment.
Not a fit: People not exposed to dolutegravir, those without pregnancy exposure concerns, or those whose neurological issues have other known causes are unlikely to benefit directly from this work.
Why it matters
Potential benefit: Could enable safer use of dolutegravir in pregnancy by identifying ways to prevent or reduce harm to fetal brain development.
How similar studies have performed: Some clinical reports and animal studies have raised concerns and preliminary lab work suggests a plausible mechanism, but protective therapies for this specific issue remain novel and unproven.
Where this research is happening
OMAHA, UNITED STATES
- UNIVERSITY OF NEBRASKA MEDICAL CENTER — OMAHA, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: BADE, ADITYA N — UNIVERSITY OF NEBRASKA MEDICAL CENTER
- Study coordinator: BADE, ADITYA N
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.