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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Labo'Life

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 CIN I, and current cytology presenting ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H or current diagnosis of CIN I at the cervical smear,

• 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 cervical smear,

• 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.