Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| C14 | — | UNRESOLVED | — |
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV | — | UNRESOLVED | — |
| HPV-induced Cancers | — | UNRESOLVED | — |
| HPV Infections | — | UNRESOLVED | — |
| Monoterpenoid Zinc Tetra-ascorbo-camphorate | — | UNRESOLVED | — |
| Trial | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Distilled water group | Drug | — | UNRESOLVED |
| The monoterpenoid zinc tetra-ascorbo-camphorate ("C14") | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- C14 arm
- description
- In this arm, particpants will received by vaginal syringe, 5ml of 1% C14, twice a day for 7 days, starting the first cure during the follicular phase of the cycle, just after the last menstrual period (S1), the second cure the following month (S5), the third cure 4 weeks later (S9) and the last cure 8 weeks later (S13).
- interventionNames
- Drug: The monoterpenoid zinc tetra-ascorbo-camphorate ("C14")
- type
- PLACEBO_COMPARATOR
- label
- Control arm
- description
- In this arm, particpants will received by vaginal syringe, 5ml of distilled water, twice a day for 7 days, starting the first cure during the follicular phase of the cycle, just after the last menstrual period (S1), the second cure the following month (S5), the third cure 4 weeks later (S9) and the last cure 8 weeks later (S13).
- interventionNames
- Drug: Distilled water group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * sexually-active women * aged at least 30 years old * who will give their informed consent to participate in the study. Exclusion Criteria: * Pregnant * breastfeeding and post-partum women will not be accepted in the study. * 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 * women who are unable to follow the study protocol.
References
Publications (3)
- BACKGROUNDSaidi H, Jenabian MA, Gombert B, Charpentier C, Mannarini A, Belec L. Pre-clinical development as microbicide of zinc tetra-ascorbo-camphorate, a novel terpenoid derivative: potent in vitro inhibitory activity against both R5- and X4-tropic HIV-1 strains without significant in vivo mucosal toxicity. AIDS Res Ther. 2008 Jun 3;5:10. doi: 10.1186/1742-6405-5-10. PMID 18522743
- BACKGROUNDMutombo AB, Tozin R, Simoens C, Lisbeth R, Bogers J, Van Geertruyden JP, Jacquemyn Y. Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study). Contemp Clin Trials Commun. 2017 Sep 28;8:135-139. doi: 10.1016/j.conctc.2017.09.008. eCollection 2017 Dec. PMID 29696202
- BACKGROUNDMboumba Bouassa RS, Gombert B, Mwande-Maguene G, Mannarini A, Belec L. In vitro inhibitory activity against HPV of the monoterpenoid zinc tetra-ascorbo-camphorate. Heliyon. 2021 Jun 6;7(6):e07232. doi: 10.1016/j.heliyon.2021.e07232. eCollection 2021 Jun. PMID 34159277