Evaluating the safety of a long-acting HIV medication during early pregnancy.
In vivo Evaluation of Safety and Pharmacology of the Sustained Release Formulation of Dolutegravir in Pre-Conception and Early Stages of Pregnancy in Animal Models
This study is looking at how safe a new version of the HIV medication dolutegravir is for women who are planning to get pregnant or are in early pregnancy, by testing it in animals to see if it could cause any problems for the mother or baby.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Univ of North Carolina Chapel Hill NIH-funded |
| Lab location | 1 site (Chapel Hill, United States) |
| Project ID | NIH-10674989 on NIH RePORTER |
What this research studies
This research investigates the safety and pharmacology of a new long-acting formulation of dolutegravir, an antiretroviral medication, specifically during pre-conception and early pregnancy stages. Using animal models, the study aims to assess the potential risks associated with prolonged exposure to this medication, particularly concerning birth defects. The approach involves administering the drug and monitoring its effects on both the mother and developing embryos, which will help determine the safety of this treatment for women of childbearing age. The findings could provide critical insights into the use of dolutegravir in pregnant women and inform future treatment guidelines.
Who could benefit from this research
Good fit: Ideal candidates for this research include women of childbearing age who are undergoing HIV treatment or prevention.
Not a fit: Patients who are not pregnant or not planning to conceive may not receive direct benefits from this research.
Why it matters
Potential benefit: If successful, this research could lead to safer HIV treatment options for women during pregnancy, reducing the risk of birth defects.
How similar studies have performed: Previous research has shown the effectiveness of long-acting antiretroviral therapies, but the specific safety of dolutegravir during pregnancy remains to be fully established.
Where this research is happening
Chapel Hill, United States
- Univ of North Carolina Chapel Hill — Chapel Hill, United States (Active)
Researchers
- Principal investigator: Kovarova, Martina — Univ of North Carolina Chapel Hill
- Study coordinator: Kovarova, Martina
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.