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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- genital HR-HPV load
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •sexually-active women
- •aged at least 30 years old
- •who will give their informed consent to participate in the study.
排除标准
- •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.
研究组 & 干预措施
C14 arm
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).
干预措施: The monoterpenoid zinc tetra-ascorbo-camphorate ("C14") (Drug)
Control arm
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).
干预措施: Distilled water group (Drug)
结局指标
主要结局
genital HR-HPV load
时间窗: From enrollment to the end of treatment at 16 weeks
次要结局
- Virological cytological(From enrollment to the end of treatment at 16 weeks)
研究者
Serge Tonen-Wolyec
Infectiologist, MD, PhD; Academic General Secretary of the University of Bunia; Member of the Société Africaine sur le SIDA (SAA) and Société Française de Microbiologie (SFM).
University of Kinshasa