HPV infection Infections and Infestations
Conditions
Interventions
Patient recruitment: PAP smears with mild anomalies (atypical squamous cells of undetermined significance [ASCUS] or LSIL) and/or a cervical biopsy-confirmed CIN 1, and a positive HPV DNA test. HPV in
Sponsors
Ospedale dei Bambini Vittore Buzzi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 30-45 years 2. Persistent positive cytological LSIL and/or histological CIN 1 and/or HPV HR test for at least 12 months 3. Absence of contraindications to the proposed therapies 4. Read and signed informed consent
Exclusion criteria
Exclusion criteria: 1. Active vulvovaginal infections at the time of their gynaecological examination 2. Genital bleeding of unknown origin 3. Pregnancy 4. Menopause (absence of menstruation for 12 months) 5. Diagnosis of or under therapy for previous CIN2+ lesions 6. Immune-depressed, or with infections caused by human immunodeficiency virus (HIV-positive) 7. Patients concomitantly included in different interventional clinical trials 8. Unwillingness to provide informed consent to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HR-HPV clearance measured using PCR at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| LSIL/CIN 1 regression measured using Pap smear/histology at 6 months | — |
Countries
Italy
Outcome results
None listed