Investigating how dolutegravir affects pregnant women and the risk of birth defects.
Official title: Defining the impact of dolutegravir on the maternal metabolic environment and its implications on risk of congenital anomalies.
Funded at University Health Network · NIH-10840973 · Data updated 2026-11-12
This study is looking at how the medication dolutegravir (DTG) affects the health of pregnant women with HIV and their babies, specifically to see if it might be linked to certain birth defects, and it aims to help ensure that DTG is safe for both moms and their little ones.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University Health Network NIH-funded |
| Lab location | 1 site (Toronto, Canada) |
| Project start | September 20, 2020 |
| Project end | June 30, 2026 |
| Funding year | 2024 |
| Award (this year) | $226,760 |
| NIH project number | 5R01HD104553-05 |
| Project ID | NIH-10840973 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are pregnant women living with HIV who are considering or currently using dolutegravir as part of their antiretroviral therapy.
✕Less likely to help
Patients who are not pregnant or those not living with HIV may not receive any benefit from this research.
What this research studies
This research examines the effects of dolutegravir (DTG), an antiretroviral medication, on the metabolic environment of pregnant women living with HIV. It aims to understand the potential link between DTG use and an increased risk of congenital anomalies, particularly neural tube defects. By utilizing both animal studies and clinical samples from Botswana, the research will explore the biological pathways that may contribute to these risks. The study seeks to clarify the safety of DTG for pregnant women and their babies.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment guidelines for pregnant women with HIV, ensuring safer outcomes for both mothers and their infants.
How similar studies have gone: Previous studies have shown mixed results regarding the association between dolutegravir and neural tube defects, indicating that this research is addressing a critical and somewhat novel area of inquiry.
Where this research is happening
-
University Health Network
Toronto, Canada Active
Researchers
- Principal investigator: Serghides, Lena — University Health Network
- Study coordinator: Serghides, Lena
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.