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

The study duration will be 72 months with 60 months of inclusion (that may be extended if the expected number of patients is not reached after 60 months) and 12 months of follow-up.

Patients aged between 25 and 45 years presenting a diagnosis of HR-HPV infection during the routine screening visit for cervical cancer prevention.

The total number of patients to include will be 284 with 142 patients per group.

Primary objective:

Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.

Secondary objectives:

Comparison of 2LPAPI® versus placebo on:

• HR-HPV infection clearance rate at 6-month visits,
• HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits,
• Evolution of cytology,
• Normalization of cytology for the subpopulation of patients with a baseline non normal cytology,
• Safety: adverse events (AEs) and serious adverse events (SAEs), considered as related or not to the study drug.

Treatment phase:

Group n°1 = 2LPAPI® (6 months of treatment) Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the clearance of HR-HPV is done and the cytology is normal.

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.