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Study on the Effectiveness of 2LPAPI with Interferon Alfa in Clearing Genital HPV Infections in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of Human Papillomavirus (HPV) infection, specifically targeting high-risk types that can lead to genital infections. The treatment being tested is called 2LPAPI, which is a combination of several active substances including interferon alfa, ciclosporin A, interleukin-1, interleukin-2, ribonucleic acid, and specific nucleic acids known as SNA-HLA II and SNA-PAPI. These substances are designed to work together to help clear the virus from the body.

The purpose of this study is to compare the effectiveness of 2LPAPI with a placebo in clearing high-risk HPV infections over a period of 12 months. Participants in the study will receive either the 2LPAPI treatment or a placebo, and their progress will be monitored at regular intervals. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will have follow-up visits to check the status of the HPV infection and any changes in their health. The main goal is to see if the 2LPAPI treatment can effectively clear the HPV infection by the end of the study period. Additionally, the study will monitor the safety of the treatment by recording any side effects or adverse events that may occur. This research aims to provide valuable information on a potential new treatment option for those affected by high-risk HPV infections.

1 joining the study

Upon joining the study, the participant is required to sign an informed consent form. This indicates understanding and agreement to follow the study’s requirements.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes verifying age, contraceptive use, recent cytology results, and a stable sexual relationship. A diagnosis of high-risk human papillomavirus (HR-HPV) is also confirmed.

3 medication administration

Participants receive either the study medication, 2LPAPI granules, or a placebo. The medication is administered through oromucosal use, which means it is taken by mouth and absorbed through the mucous membranes.

4 follow-up visits

Follow-up visits occur at 6 months and 12 months. During these visits, the clearance of HR-HPV infection is evaluated. Cytology results are also assessed to determine any changes.

5 evaluation of results

The primary goal is to assess HR-HPV infection clearance at the 12-month visit. Secondary evaluations include infection clearance at the 6-month visit, changes in cytology, and safety assessments for any adverse events.

Who Can Join the Study?

  • Women between 25 and 45 years old.
  • Women who can have children must be using effective birth control.
  • Patient must have had a cervical screening test (cytology) in the last 3 years, showing normal results or mild abnormalities like LSIL (Low-Grade Squamous Intraepithelial Lesion) or CIN I (Cervical Intraepithelial Neoplasia grade I).
  • Current cervical screening test results must be normal or show mild abnormalities such as ASC-US (Atypical Squamous Cells of Undetermined Significance), AGUS (Atypical Glandular Cells of Undetermined Significance), LSIL, ASC-H (Atypical Squamous Cells – cannot exclude HSIL), AGC (Atypical Glandular Cells), or LSIL+ASC-H, or a current diagnosis of CIN I.
  • Patient must have a diagnosis of HR-HPV (High-Risk Human Papillomavirus) from the current cervical sample.
  • Patient must report having a stable sexual relationship, meaning a steady sexual partner for the duration of the study.
  • Patient must be able to understand and follow the study requirements.
  • Patient must sign the Informed Consent Form, which is a document that explains the study and confirms their willingness to participate.

Who Cannot Join the Study?

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes people who might have a harder time making decisions for themselves or who need extra protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centrul Medical Euromed S.R.L. Bucharest Romania
Spitalul Clinic Nicolae Malaxa Bucharest Romania
Primed Medicine Omc S.R.L. Bucharest Romania
Centrul Medical Paleologu S.R.L. Bucharest Romania

Other Sites

Site Name City Country Status
Lotus Med S.R.L. Bucharest Romania
Private practice of Dr Benoit Moons Namur Belgium
University Childrens Hospital Queen Fabiola Brussels Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
centre Hospitalier de Wallonie Picarde Tournai Belgium
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Cscqilzs Sranfrynoi Kiiruqr Sismqgqk Brussels Belgium
Chlomu Hdwdrdvangn Rwozi Awkahp Muymjlr Malmedy Belgium
Holnnoxr Ixec Sms &xhrqdj Sfym Ekkcnhhfekjknwwts Ixelles Belgium
Agpq Moryjkd Sapgsb Bucharest Romania
Cms dk Cxplfqetp Hntyhfy Cxgyh Midjo Cvbog Charleroi Belgium
Ccs Chitkuhy Rrcwrydw Nhpmoic Sqwxnh Bucharest Romania
Ccejugc Nzm Axj Sctjwl Pitesti Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.10.2020
Romania Romania
Recruiting
15.10.2020

Trial locations

Investigated drugs:

2LPAPI: This is an investigational medication being studied for its potential to help clear genital high-risk human papillomavirus (HR-HPV) infections. The trial aims to determine if this medication can effectively eliminate the virus from the body over a period of 12 months.

Human Papillomavirus Infection – This is a common viral infection caused by the human papillomavirus (HPV), which can affect the skin and mucous membranes. It is often transmitted through direct skin-to-skin contact, including sexual contact. There are many types of HPV, some of which can lead to the development of warts, while others are associated with certain cancers. The infection may not always cause symptoms, and many people may not realize they are infected. In some cases, the body’s immune system clears the virus naturally over time. However, persistent infection with high-risk types of HPV can lead to more serious health issues.

Trial ID:
2024-513969-39-00
Protocol code:
LLB-2017-01
NCT ID:
NCT04232917
Trial Phase:
Therapeutic confirmatory (Phase III)

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