[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567781":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":56,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"MGB Pharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"C14 arm","EXPERIMENTAL","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).",[13],"Drug: The monoterpenoid zinc tetra-ascorbo-camphorate (\"C14\")",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","PLACEBO_COMPARATOR","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).",[19],"Drug: Distilled water group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","The monoterpenoid zinc tetra-ascorbo-camphorate (\"C14\")","The 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Distilled water group","Instead of C14, distilled water will be administered in this group.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Serge TONEN WOLYEC, MD, PhD","CONTACT","+243815791076","wolyec@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":26},"Raelle ATENYI KASEMIRE, MD","+24382236024",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Polyclinique Citadelle","Bunia","Ituri","Democratic Republic of the Congo","CD",{"type":48,"coordinates":49},"Point",[50,51],30.25224,1.55941,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":35,"phoneExt":26,"email":36},"Serge TONEN WOLYEC",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":60,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","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","100567781","phase-1-tolerance-and-effectiveness-of-c14-on-hpv-infection-100567781",false,"NCT06672653","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","PREPAP","Inclusion Criteria:\n\n* sexually-active women\n* aged at least 30 years old\n* who will give their informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant\n* breastfeeding and post-partum women will not be accepted in the study.\n* previous cervical surgery, medical history of any severe diseases, intake or application of other antivirals\n* known or suspected allergic or adverse response to the investigational product or its components\n* women who are unable to follow the study protocol.","FEMALE","30 Years","65 Years",{"count":73,"type":74},66,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE1","PHASE2","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.\n\nThe 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:\n\nDoes 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.\n\nParticipants will\n\nreceive 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.",[81,82,83,84,85,86,87],"HPV-induced Cancers","HPV Infections","HIV","Cervical Cancers","Trial","C14","Monoterpenoid Zinc Tetra-ascorbo-camphorate","NOT_YET_RECRUITING","2024-11-01",{"date":91,"type":92},"2024-11-04","ACTUAL",{"date":94,"type":74},"2024-11-15",{"date":96,"type":74},"2025-07-15",{"name":5,"class":6},1]