Treatment for clearing genital HR-HPV infections using 2LPAPI®
Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
This study is testing if a new immune treatment called 2LPAPI® can help women aged 25 to 45 clear high-risk HPV infections more effectively than a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Labo'Life Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 12 sites (Brussels and 11 other locations) |
| Trial ID | NCT04232917 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of 2LPAPI®, an immune regulator, in clearing high-risk human papillomavirus (HR-HPV) infections in women aged 25 to 45. Participants will be randomly assigned to receive either 2LPAPI® or a placebo for six months, followed by a six-month follow-up period. The primary objective is to compare the clearance rates of HR-HPV infections between the two groups after 12 months. Secondary objectives include assessing the clearance rates at six months, the evolution of cytology, and the safety of the treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 to 45 with a diagnosis of HR-HPV infection and specific cytological findings.
Not a fit: Patients with high-grade lesions or those who have undergone total hysterectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective option for clearing HR-HPV infections, potentially reducing the risk of cervical cancer.
How similar studies have performed: Previous observational data on 2LPAPI® have shown beneficial effects on HPV clearance, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels and 11 other locations
- CHU Saint-Pierre — Brussels, Belgium (Recruiting)
- Clinique St Jean — Brussels, Belgium (Recruiting)
- CHU Brugmann — Brussels, Belgium (Recruiting)
- Hôpitaux Iris Sud - Iris Zuid Ziekenhuis — 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)
- Belgium — Namur, Belgium (Active_not_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)
Study contacts
- Study coordinator: Laura FERTE
- Email: laura.ferte@labolife.com
- Phone: +32499717964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.