Tolerance and Effectiveness of C14 on HPV Infection

NCT06672653 | Not Yet Recruiting Phase 1

• 1 other identifier: PREPAP/CER/006/GEAK/2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV-induced Cancers; HPV Infections; HIV; Cervical Cancers; Trial; C14; Monoterpenoid Zinc Tetra-ascorbo-camphorate

Outcome Measures

Primary Outcomes (1)

• genital HR-HPV load

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (1)

• Virological cytological

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

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).

Drug: The monoterpenoid zinc tetra-ascorbo-camphorate ("C14")

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).

Drug: Distilled water group

Interventions

The monoterpenoid zinc tetra-ascorbo-camphorate ("C14") DRUG

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.

C14 arm

Distilled water group DRUG

Instead of C14, distilled water will be administered in this group.

Control arm

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sexually-active women
• aged at least 30 years old
• who will give their informed consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MGB Pharma: lead

Study Sites (1)

Polyclinique Citadelle

Bunia, Ituri, Democratic Republic of the Congo

Location

Related Publications (3)

• Saidi 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 BACKGROUND

• Mutombo 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 BACKGROUND

• Mboumba 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 BACKGROUND

Related Links

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MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

Carbon-14

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Serge TONEN WOLYEC, MD, PhD

CONTACT

+243815791076; wolyec@gmail.com

Raelle ATENYI KASEMIRE, MD

CONTACT

+24382236024

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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).

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: July 15, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)