Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
ConditionHuman Papilloma Virus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorLabo'Life
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
2LPAPI®
DrugTreatment
Placebo
DrugPlacebo
Treatment groups
284 Participants
are divided into 2 treatment groupsGroup A: 2LPAPI® armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.
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.
Time frame
12 monthsSecondary outcomes
1
Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate at 6-month visits.
The objective of this outcome will be to compare the number of patients with positive HR-HPV infection status observed at 6 months and the number of patients with positive HR-HPV infection status observed at the inclusion.
Time frame
6 months2
Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits.
The objective of this outcome will be to compare the number of patients with specific type of HPV infection observed at 6 and 12 months and the number of patients with specific HPV infection status observed at the inclusion.
Time frame
6 and 12 months3
Evolution of cytology (normalization, stagnation or worsening) at 6-month and 12-month visits.
The objective of this outcome will be to compare the evolution of the cytology at 6-month and 12-month visits.
Time frame
6 and 12 months4
Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non-normal cytology.
The objective of this outcome will be to compare the number of patients with a normal cytology at 6-month and 12-month visits in the subpopulation of patients with a baseline non-normal cytology.
Time frame
6 and 12 months Source ClinicalTrials.gov