Clinical trial NCT04232917: Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
Official title: Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Human Papilloma Virus
Lead sponsor: Labo'Life
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 284
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate at 6-month visits.
timeFrame: 6 months
measure: Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits.
timeFrame: 6 and 12 months
measure: Evolution of cytology (normalization, stagnation or worsening) at 6-month and 12-month visits.
timeFrame: 6 and 12 months
measure: Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non-normal cytology.
timeFrame: 6 and 12 months
measure: Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
timeFrame: 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: Clinique St Jean
city: Bruxelles
country: Belgium
facility: Hôpitaux Iris Sud - Iris Zuid Ziekenhuis
city: Charleroi
country: Belgium
facility: Hôpital Civil Marie Curie ISPPC
city: Malmédy
country: Belgium
facility: Centre Hospital Reine Astrid Malmedy (CHRAM)
city: Namur
country: Belgium
facility: Belgium
city: Namur
country: Belgium
facility: Belgium
city: Namur
country: Belgium
facility: Cabinet privé
city: Namur
country: Belgium
facility: UCL Namur - site Sainte Elisabeth
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre Ottignies (CSPO)
city: Tournai
country: Belgium
facility: CHWAPI
Study officials:
References: