Repurposed Antiretroviral Therapies to Eliminate Cervical Cancer
Official title: RepurPosed AntiretrOviraL ThErapieS to EliminAte Cervical Cancer (POLESA Trial)
Funded at University of Cincinnati · NIH-11535226 · Data updated 2026-11-12
A pilot study tests a self-administered vaginal capsule with protease inhibitors to safely treat cervical precancer (CIN 2/3) in women, using a non-invasive approach.
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 | 2026 |
| Award (this year) | $195,214 |
| NIH project number | 3R37CA284033-04S1 |
| Project ID | NIH-11535226 on NIH RePORTER |
Who could benefit from this research
✓Could help
Women in the US with CIN 2/3 seeking non-invasive treatment options and willing to use a self-administered vaginal capsule.
✕Less likely to help
Individuals with advanced cervical cancer or those unable to tolerate vaginal therapies may not benefit.
What this research studies
This Phase 1a/1b pilot study at the University of Cincinnati will test a non-invasive, self-administered vaginal capsule containing LPV/r for CIN 2/3. Researchers will evaluate safety and how well participants accept the treatment, using escalating durations (7, 14, or 21 days) in a small group of 15 US women. The goal is to determine whether this LPV/r formulation is tolerable and shows early signs of activity against precancerous cervical changes, potentially offering a non-surgical option. The study builds on preclinical data and prior small human studies suggesting anti-cancer and anti-HPV activity of LPV/r. If promising, findings could guide larger trials and shift future care toward less invasive alternatives.
Why it matters
Potential benefit: If successful, this non-surgical treatment could reduce the need for invasive procedures and associated risks for CIN 2/3.
How similar studies have gone: Preclinical and early clinical data have hinted at activity of LPV/r against cervical precancer, but this exact formulation and dosing require confirmation.
Where this research is happening
-
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.