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.
sexually-active women
aged at least 30 years old
who will give their informed consent to participate in the study.
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
Parallel
The monoterpenoid zinc tetra-ascorbo-camphorate ("C14")
DrugThe trial phase will consist of hospital administration by vaginal syringe of 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). Gynaecological follow-up with HPV molecular testing and cervical smear will be performed two days after each course of treatment at S2, S6, S10, S14 and 2 weeks after the last course of treatment (S16). Unprotected sexual intercourse will not be permitted during each course of treatment, and for at least 72 hours before each genital swab.
Distilled water group
DrugInstead of C14, distilled water will be administered in this group.
genital HR-HPV load
Virological cytological
The aim here will be to verify whether C14 could cure low-grade cervical lesions.
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MGB Pharma
Lead sponsor
University of Kinshasa
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: