Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
Labo'Life
284 participants
Oct 17, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria12
- 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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Interventions
Treatment
Placebo
Locations(12)
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NCT04232917