Repurposed HIV drugs for cervical precancer
RepurPosed AntiretrOviraL ThErapieS to EliminAte Cervical Cancer (POLESA Trial)
This project tests a self‑inserted vaginal capsule of lopinavir/ritonavir for women with cervical precancer (CIN 2/3).
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 ID | NIH-11158807 on NIH RePORTER |
What this research studies
You would be one of 15 women with CIN 2/3 treated at a colposcopy clinic in Cincinnati who self‑insert a vaginal capsule containing lopinavir/ritonavir for short periods (7, 14, or 21 days) to check safety and tolerability. The trial uses a dose‑duration escalation so small groups try longer treatment periods while doctors closely monitor symptoms and side effects. Researchers will also look for early signs the drug affects HPV-related precancer using colposcopy and biopsies as needed. The formulation uses a new 12:1 lopinavir-to-ritonavir ratio based on lab work and earlier proof-of-concept results.
Who could benefit from this research
Good fit: Women diagnosed with cervical intraepithelial neoplasia grade 2 or 3 (CIN 2/3) who can attend the Cincinnati clinic and are willing to self‑insert the vaginal capsule are the intended participants.
Not a fit: People with invasive cervical cancer, pregnant people, or those allergic to or taking medications that interact with lopinavir/ritonavir are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this could become a non‑invasive, fertility‑preserving alternative to surgical treatments for cervical precancer.
How similar studies have performed: A prior proof-of-concept trial using a different lopinavir/ritonavir ratio showed promising results, but this optimized 12:1 formulation is new and being piloted clinically.
Where this research is happening
Cincinnati, United States
- University of Cincinnati — Cincinnati, United States (Active)
Researchers
- Principal investigator: Pinder, Leeya F — University of Cincinnati
- Study coordinator: Pinder, Leeya F
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.