Investigating how dolutegravir may cause birth defects

Plausible Causative Mechanism for Dolutegravir Developmental Toxicity

NIH-funded research Baylor College of Medicine · NIH-10671073

This study is looking into whether the antiretroviral drug dolutegravir might be linked to birth defects in babies when taken by pregnant women, using zebrafish to help understand how the drug affects development, so we can provide clearer safety information for women who might become pregnant.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionBaylor College of Medicine NIH-funded
Lab location1 site (Houston, United States)
Project IDNIH-10671073 on NIH RePORTER

What this research studies

This research explores the potential link between the antiretroviral drug dolutegravir and the risk of birth defects, particularly neural tube defects, in infants born to mothers who took the medication during pregnancy. The study uses animal models, specifically zebrafish, to understand the mechanisms by which dolutegravir may affect embryonic development. By examining how the drug interacts with essential developmental processes, the research aims to clarify the safety of dolutegravir for women of childbearing age. The findings could lead to better guidelines for the use of this medication in pregnant women.

Who could benefit from this research

Good fit: Ideal candidates for this research include pregnant women or women of childbearing age who are receiving or considering dolutegravir as part of their HIV treatment.

Not a fit: Patients who are not pregnant or do not plan to become pregnant while on dolutegravir may not receive direct benefits from this research.

Why it matters

Potential benefit: If successful, this research could lead to improved safety guidelines for the use of dolutegravir in pregnant women, potentially reducing the risk of birth defects.

How similar studies have performed: Previous studies have indicated potential risks associated with dolutegravir, but this research aims to provide new insights into its teratogenic effects, making it a novel investigation.

Where this research is happening

Houston, United States

Researchers

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 below.
Conditions Acquired Immune Deficiency SyndromeAcquired Immuno-Deficiency SyndromeAcquired Immunologic Deficiency SyndromeAcquired Immunodeficiency Syndrome
Last reviewed 2026-06-13 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.