Repurposed Antiretroviral Therapies to Eliminate Cervical Cancer (POLESA)
Official title: RepurPosed AntiretrOviraL ThErapieS to EliminAte Cervical Cancer (POLESA Trial)
Funded at University of Cincinnati · NIH-11416551 · Data updated 2026-11-12
A early-phase trial will test a self-administered vaginal capsule containing HIV-related protease inhibitors to treat precancerous cervical lesions in women, aiming for a non-invasive option.
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) | $275,295 |
| NIH project number | 5R37CA284033-04 |
| Project ID | NIH-11416551 on NIH RePORTER |
Who could benefit from this research
✓Could help
Women in the US with CIN 2/3 (precancer) who are considering non-surgical treatment options and can attend a hospital-based clinic in Cincinnati, OH.
✕Less likely to help
Individuals without CIN 2/3 or those unable to use vaginal medications due to medical or personal considerations may not benefit.
What this research studies
This Phase 1a/1b pilot study in CIN2/3 patients will evaluate a new, non-invasive vaginal capsule of LPV/r (12:1 ratio) for safety and how acceptable it is to participants. Participants will use the capsule for 7, 14, or 21 days at a time, with close monitoring at a hospital colposcopy clinic in Cincinnati. The study builds on preclinical and early clinical data suggesting potential anti-cancer and anti-HPV activity of LPV/r, and it seeks to determine if this formulation can be feasibly used in a real-world setting. If safety and tolerability are confirmed, the findings could pave the way for later studies on effectiveness and potential non-surgical management of CIN.
Why it matters
Potential benefit: If successful, the capsule could offer a non-invasive treatment option that minimizes pain, bleeding, and fertility risks compared with current procedures.
How similar studies have gone: Prior small trials showed some promise with LPV/r against cervical abnormalities, but this specific 12:1 formulation in a non-invasive capsule is novel and exploratory.
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
Other NIH-funded projects on the same topics.
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Community and digital tools to reduce HPV and cervical cancer burden
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Community and digital tools to reduce HPV and cervical cancer in women with HIV
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mSaada: a mobile tool to boost cervical cancer screening in western Kenya
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HPV self-collection in HIV care to screen for cervical cancer in Ethiopia
A patient-centered program tests a simple HPV self-collection approach within HIV clinics in Ethiopia to help detect cervical cancer earlier.
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Hybrid approach to boost cervical cancer screening in Uganda
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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.