NCT06672653Not yet recruitingPhase 1/2
Tolerance and Effectiveness of C14 on HPV Infection
PREPAP Study: Tolerance and Effectiveness of the Monoterpenoid Zinc Tetra-ascorbo-camphorate (C14) on the Genital Load of Oncogenic HPV (HR-HPV) and Precancerous Cervical Lesions: Research With Direct Individual Benefit
Source: ClinicalTrials.gov · Last updated 4 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The zinc monoterpenoid tetra-ascorbo-camphorate possesses broad-spectrum anti-viral properties in vitro, particularly against HIV, HSV and HPV. Its C14 formulation could be a promising candidate for in vivo clinical evaluation as a potential microbicide or therapeutic drug. The aim of this clinical trial is to determine whether C14 is effective in reducing the genital viral load of HR-HPV and in treating low-grade dysplastic lesions of the cervix. It will also determine the tolerability of C14. The main questions to be answered by the clinical trial are as follows: Does C14 reduce the genital HR-HPV viral load in participants with persistent HR-HPV infections? What medical problems do participants experience when taking C14? Researchers will compare C14 to a placebo (a similar substance that contains no drug) to see if C14 is effective in reducing genital C14 viral load and in treating low-grade dysplastic lesions of the cervix. Participants will receive four monthly treatments (5ml of C14 dissolved in distilled water administered twice daily \[morning and evening\] for seven days via vaginal syringe during the follicular phase) of C14 or placebo for 4 months and visit the clinic once every 2 weeks for examinations and tests. They will keep a diary of their symptoms and the number of times they keep the hospital appointment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 1 Nov 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 15 Mar 2025
- Lead sponsor
- MGB Pharma
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT06672653
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 66
- From 15 Nov 2024 to the primary completion date, 15 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous cervical surgery, medical history of any severe diseases, intake or application of other antivirals
- known or suspected allergic or adverse response to the investigational product or its components
Other
- Pregnant
- breastfeeding and post-partum women will not be accepted in the study.
- women who are unable to follow the study protocol.
Who the study is looking for
- sexually-active women
- aged at least 30 years old
- who will give their informed consent to participate in the study.
Age in the registry: 30 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Polyclinique Citadelle Coordinator of this site? Confirm its status | Bunia | Democratic Republic of the Congo | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.