HPV Disease, HPV Genital Infection, HPV Infection, HPV Integration, HPV Persistence, Low Grade Squamous Intraepithelial Lesions of the Cervix
Conditions
Brief summary
This interventional, single-center, open-label randomized clinical study evaluates the efficacy of an oral dietary supplement (Pervistop®) in women with persistent Human Papillomavirus (HPV) infection. The supplement is a combination of four natural molecules: Epigallocatechin gallate (EGCG), folic acid (FA), vitamin B12 (B12), and hyaluronic acid (HA).The primary objective is to describe the effect of this association on HPV DNA integration into the host genome by measuring the clearance rate of viral oncoproteins E6 and E7. A total of 42 women aged 25 or older with persistent HPV infection and low-grade cervical lesions will be randomized 1:1 into two groups. The treated group will receive one tablet of Pervistop® daily for six months, while the control group will follow standard clinical practice. The study aims to determine if this nutritional intervention can counteract viral persistence.
Detailed description
Human Papillomavirus (HPV) is a common sexually transmitted infection that, while often regressing spontaneously, can persist. Persistent high-risk HPV infection is a major risk factor for cervical cancer because it allows viral DNA to integrate into the host genome. This integration triggers the constitutive expression of viral oncoproteins E6 and E7, which block the host's tumor suppressor genes (p53 and prb), leading to uncontrolled cell proliferation.Currently, clinical practice for low-grade lesions typically involves a surveillance approach. This study explores the use of a synergic combination of EGCG (anti-proliferative/pro-apoptotic), Vitamin B12 and Folic Acid (methylation agents), and Hyaluronic Acid (epithelial integrity) to promote viral clearance and inhibit E6/E7 expression.
Interventions
DIETARY_SUPPLEMENTEpigallocatechin gallate (EGCG), Folic Acid (FA), Vitamin B12 (B12), and Hyaluronic Acid (HA)
Participants will self-administer one oral tablet of the dietary supplement Pervistop daily
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 25 years old 2. Positive HPV DNA test with genotyping 9-24 months prior to Day 0 3. Positive HPV DNA test with genotyping at Day 0 4. Presence of an HPV-related cervical lesion within 5-24 months prior to Day 0. This lesion will be defined alternatively as: 1. Pap test: LSIL, ASC-US. 2. Colposcopic impression suggestive of a low-grade lesion. 3. Histologic report of a colposcopic biopsy consistent with a low-grade lesion. 5. Previous HPV vaccination (latest dose at least 24 months earlier than Day 0) 6. Patients able to accept and sign informed consent for the study 7. Patients able to adhere to the proposed study protocol
Exclusion criteria
1. High grade cervical lesions (HSIL) 2. Ongoing pregnancy, evaluated through a rapid chromatographic immunoassay for qualitative detection of hCG in urine 3. Ongoing breastfeeding 4. Primary or secondary immunodepression due to pharmacological treatments 5. No HPV vaccination 6. Daily assumption of other products containing green tea 7. Hypersensitivity or allergy to the substances contained in the supplement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clearance of viral oncoproteins E6 and E7 | 6 months | The percentage of participants showing a negative result for viral E6/E7 mRNA, which are key indicators of HPV DNA integration into the host genome. Analysis will be performed using the Aptima HPV assay, a transcription-mediated amplification (TMA) technique. A negative test result indicates viral clearance or loss of viral integration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV DNA Clearance Rate | 6 months | The rate of participants who test negative for high-risk HPV DNA using a multiplex PCR kit (Allplex II HPV 28 Detection). A negative result is defined as the absence of detectable high-risk HPV DNA above the analytical limit of detection |
| Treatment Adherence score | 6 months | Adherence to the oral supplementation protocol evaluated through the Morisky Medication Adherence Scale (MMAS-4) questionnaire |
Countries
Italy
Contacts
CONTACTMassimo Origoni, MD
Outcome results
None listed