NCT04232917 Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 284 participants in total. It began in 2020-10-17 with a primary completion date of 2027-03-15.

Brief Summary

Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina. The KCE Report 238Cs (2015) recommends " HR-HPV-positive women should not be offered colposcopy immediately. Triage should be done using cytology for this purpose. If cytological abnormalities (ASCUS+) are found, immediate referral should follow for diagnosis and, where appropriate, treatment. If no abnormalities are observed in triage, the subject should be offered follow-up testing (cytology) at six months. ". There is no treatment that is recommended during this lap time. The 2LPAPI® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of HR-HPV infections. Since 2LPAPI® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV. The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI® on the clearance of genital HR-HPV infections.

Eligibility Criteria

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.

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