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Clinical Trials in Belgium / NCT04232917
Recruiting Phase 4

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

NCT04232917 · tracked via the Priya Life Science Belgium tracker
Sponsor
Labo'Life
Phase
Phase 4
Started
2020-10-17
Last updated
2026-08-27

Condition(s) studied

Human Papilloma Virus

Investigational drug(s) / intervention(s)

2LPAPI®Placebo

2LPAPI®: Treatment

Placebo: Placebo

Study summary

Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina.

In Belgium, since 2025, HPV testing has become the primary screening method for cervical cancer. For women between 30 and 64 years, a clinical guideline (March 2025) from Sciensano stated the following " The triage of HPV-positive women is based on HPV type and reflex cytology outcome as a threshold for colposcopy. In 30- to 64-year-olds, triage of HR-HPV non-16/18 positives consists of an initial reflex cytology, followed by another HPV test 12 months later if the first step demonstrated Negative for Intraepithelial Lesion or Malignancy (NILM). Women who test positive on the initial HR-HPV test for the most high-risk HPV types 16 or 18 are immediately referred for colposcopy. Besides colposcopy, a reflex cytology will be performed. ". Women from 25 to 29 years are recommended to undergo a cytology testing on cervical smear as primary screening method following Sciensano clinical guideline (March 2025) recommendations. If abnormalities are detected, a HPV testing is performed. For the two age groups, if low grade abnormalities are detected with a diagnosis of HR-HPV, a second triage is recommended at 12 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

Sex
FEMALE
Min age
25 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up. — 12 months
    The primary objective of the study will be to compare the number of patients with positive HR-HPV infection status observed at 12 months and the number of patients with positive HR-HPV infection status observed at the inclusion.

Trial sites (11)

FacilityCityRegionStatus
CHU Saint-Pierre Brussels Belgium Recruiting
Clinique St Jean Brussels Belgium Recruiting
CHU Brugmann Brussels Belgium Recruiting
Hôpital Civil Marie Curie ISPPC Charleroi Belgium Active Not Recruiting
Centre Hospital Reine Astrid Malmedy (CHRAM) Malmedy Belgium Active Not Recruiting
Belgium Namur Belgium Recruiting
Cabinet privé Namur Belgium Recruiting
UCL Namur - site Sainte Elisabeth Namur Belgium Recruiting
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium Not Yet Recruiting
CHWAPI Tournai Belgium Recruiting
Spitalul Nicolae Malaxa Bucharest Romania Not Yet Recruiting

More Labo'Life trials in Belgium

Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. Recruiting
Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection Recruiting
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts Recruiting

Other trials for the same condition

Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples Recruiting
High Resolution Anuscopy Study Recruiting
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04232917 on ClinicalTrials.gov ↗ ← All trials in Belgium