Tolerance and Effectiveness of C14 on HPV Infection
brief summary
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.
detailed description
1. Rationnal :
The human papillomavirus (HPV) group includes 200 known viruses. Persistent high-risk HPV infection can cause cervical cancer, and is associated with cancers of the vulva, vagina, mouth/throat, penis and anus. Effective preventive interventions against HR-HPV exist in developed countries, such as the Gardasil and Cervarix vaccines. These interventions are implemented with great disparity in sub-Saharan Africa, where many African women carry high cervical viral loads of HR-HPV and precancerous and dysplastic lesions. The use of antimicrobial molecules would appear to be one way of improving the management of these women.
The monoterpenoid zinc tetra-ascorbo-camphorate ("C14") thus possesses pleiotropic antimicrobial properties. Several in vitro experiments have demonstrated C14's viricidal activity against HIV (Shattock, 1997; Barré-Sinoussi, 2008) and HPV (Mboumba Bouassa, 2021). A phase I/II clinical trial of C14's tolerance-efficacy on genital oncogenic HPV load (HR-HPV) and on precancerous cervical lesions is now envisaged, with a view to boosting the development of C14 through a larger-scale trial. 2. Objectives
2.1. General objective
This research aims to contribute to the reduction of cervical cancer morbimortality through the in vivo evaluation of C14 as a potential microbicide or therapeutic drug against oncogenic HPV.
2.2. Specific objectives : * Determine whether C14 is effective in reducing the genital viral load of HR-HPV and in treating low-grade dysplastic lesions of the cervix; * Evaluate the tolerability of C14 among volunteers. 3. Methods
3.1. Study design
The present study is a double-blind randomized placebo-controlled clinical trial. It will include 66 patients in Polyclinique Citadelle, a health centre in Bunia, Democratic Republic of the Congo. It is estimated to last 18 weeks considering final data collection for primary outcome measurements.
3.2. Participants
1. Inclusion criteria:
The targeted population is all sexually-active women, aged at least 30 years old and who will give their informed consent to participate in the study.
The reason for this target population is based on the natural history of HPV infection. HPV is acquired at the onset of sexual activity which occurs at around 15 to 20 years of age. Its prevalence is very high at a younger age and is often transient because most women will spontaneously eliminate the virus after some years. When it persists, HPV infection can take in average 10 years to lead to cervical cancer. Thus, testing is projected to start 10 years later after sexual debut in this case at 25 to 30 years old onward. 2. Exclusion Criteria:
official title
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