Actively Recruiting
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
Led by Labo'Life · Updated on 2024-10-31
284
Participants Needed
12
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 25 to 45 years
- Women of childbearing age using effective contraception
- Last cytology test within 3 years showing normal results or mild abnormalities (LSIL or CIN I)
- Current cytology results including normal, ASC-US, AGUS, LSIL, ASC-H, AGC or diagnosis of CIN I
- Diagnosis of high-risk HPV infection at current cervical collection
- Stable sexual relationship during the study period
- Ability to understand and follow study requirements
- Signed informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Diagnosis of HSIL at cytology or CIN II or CIN III at histology
- HPV vaccination within the last month
- Previous total hysterectomy
- Immunotherapy or micro-immunotherapy in the last 6 months
- Known lactose intolerance
- Participation in another clinical study within the past 3 months
- Unwilling or unable to complete 12-month follow-up or likely to relocate
- Severe immunodeficiency requiring long-term treatment, chemotherapy, or radiotherapy
- Use of certain homeopathic or phytotherapy treatments
- Use of or addiction to recreational drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
CHU Saint-Pierre
Brussels, Belgium, 1000
Actively Recruiting
2
Clinique St Jean
Brussels, Belgium, 1000
Actively Recruiting
3
CHU Brugmann
Brussels, Belgium, 1020
Actively Recruiting
4
Hôpitaux Iris Sud - Iris Zuid Ziekenhuis
Brussels, Belgium, 1050
Actively Recruiting
5
Hôpital Civil Marie Curie ISPPC
Charleroi, Belgium, 6042
Active, Not Recruiting
6
Centre Hospital Reine Astrid Malmedy (CHRAM)
Malmedy, Belgium, 4960
Active, Not Recruiting
7
Belgium
Namur, Belgium, 5000
Actively Recruiting
8
Belgium
Namur, Belgium, 5000
Active, Not Recruiting
9
Cabinet privé
Namur, Belgium, 5000
Actively Recruiting
10
UCL Namur - site Sainte Elisabeth
Namur, Belgium
Actively Recruiting
11
Clinique Saint-Pierre Ottignies (CSPO)
Ottignies, Belgium, 1340
Not Yet Recruiting
12
CHWAPI
Tournai, Belgium, 7000
Actively Recruiting
Research Team
L
Laura FERTE
CONTACT
C
Charlotte BOLLE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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