Vaginal antiviral capsule to treat cervical precancer
Official title: RepurPosed AntiretrOviraL ThErapieS to EliminAte Cervical Cancer (POLESA Trial)
Funded at University of Cincinnati · NIH-11414851 · Data updated 2026-11-12
This trial tests a self-inserted vaginal capsule containing the HIV drugs lopinavir/ritonavir to try to clear cervical precancer (CIN2/3) in women.
Quick facts
| Grant type | R37 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Cincinnati NIH-funded |
| Lab location | 1 site (Cincinnati, United States) |
| Project start | August 1, 2023 |
| Project end | July 31, 2028 |
| Funding year | 2025 |
| Award (this year) | $195,214 |
| NIH project number | 3R37CA284033-03S1 |
| Project ID | NIH-11414851 on NIH RePORTER |
Who could benefit from this research
✓Could help
Women diagnosed with cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) who can travel to the Cincinnati colposcopy clinic and are willing to self-administer a vaginal capsule would be the ideal candidates.
✕Less likely to help
People with invasive cervical cancer or those who require immediate surgical treatment are unlikely to benefit from this pilot.
What this research studies
If I join, I would self-insert a vaginal capsule that delivers lopinavir/ritonavir in a new 12:1 ratio for a short course of 7, 14, or 21 days depending on the dose group. The pilot enrolls 15 women with cervical precancer (CIN2/3) at a colposcopy clinic in Cincinnati, OH as a Phase 1a/1b safety and acceptability study. Clinic visits will check for side effects, how easy the capsule is to use, and early signs that the treatment is acting on HPV or the precancer. Doctors will collect exams and lab tests to look for healing, HPV changes, bleeding, or other adverse effects during follow-up.
Why it matters
Potential benefit: If successful, this could offer a non-invasive, self-administered option that avoids surgery and may reduce pain, bleeding, scarring, and fertility risks.
How similar studies have gone: A prior proof-of-concept trial using a different lopinavir/ritonavir ratio reported promising results and laboratory studies support the approach, but the 12:1 capsule formulation is newly tested in humans.
Where this research is happening
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University of Cincinnati
Cincinnati, United States Active
Researchers
- Principal investigator: Pinder, Leeya F — University of Cincinnati
- Study coordinator: Pinder, Leeya F
Related research
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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.