Treatment for clearing genital HR-HPV infections using 2LPAPI®

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of 2LPAPI®, an immune regulator, in clearing high-risk human papillomavirus (HR-HPV) infections in women aged 25 to 45. Participants will be randomly assigned to receive either 2LPAPI® or a placebo for six months, followed by a six-month follow-up period. The primary objective is to compare the clearance rates of HR-HPV infections between the two groups after 12 months. Secondary objectives include assessing the clearance rates at six months, the evolution of cytology, and the safety of the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women 25-45 years,
* Women of childbearing age under effective contraception,
* Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology,
* Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology,
* Patient with HR-HPV diagnosis at the current cervical collection,
* Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
* Patient having faculties to understand and respect the constraints of the study,
* Signature of the Informed Consent Form.

Exclusion Criteria:

* Pregnant or breastfeeding woman,
* Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology,
* Patient having received HPV vaccination in the last month,
* Patient previously subject to total hysterectomy,
* Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,
* Patient with known lactose intolerance,
* Patient who participated in a clinical study in the previous 3-months' period,
* Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,
* Patient with severe immunodeficiency disease requiring long term treatment (\*) or under chemotherapy or radiotherapy,
* Patient under listed homeopathic or phytotherapy treatment (see protocol),
* Patient using or addicted to recreational drugs.

(\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Where it's running

• CHU Saint-Pierre
  Brussels, Belgium Recruiting
• Clinique St Jean
  Brussels, Belgium Recruiting
• CHU Brugmann
  Brussels, Belgium Recruiting
• Belgium
  Namur, Belgium Recruiting
• Cabinet privé
  Namur, Belgium Recruiting
• UCL Namur - site Sainte Elisabeth
  Namur, Belgium Recruiting

Study contacts

• Study coordinator: Laura FERTE
• Email: laura.ferte@labolife.com
• Phone: +32499717964

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.