Malmedy

This research is focused on women aged 25 to 45 years who have been diagnosed with high-risk human papillomavirus HR-HPV infections during routine cervical cancer screening. The study aims to evaluate the effectiveness of 2LPAPI4, an immune regulator used to treat HR-HPV infections, in clearing genital HR-HPV compared to a placebo. The trial follows recommendations for triage and follow-up in HR-HPV-positive women to better understand treatment impact on infection clearance and cytology changes. Participants will be randomly assigned to one of two groups one receiving 2LPAPI4 capsules and the other receiving placebo capsules. Each group will take one capsule daily, 15-30 minutes before breakfast on an empty stomach, for six continuous months. Following the treatment phase, there is a six-month follow-up period to monitor the clearance of the infection and normalization of cytology. During the study, participants will undergo regular cervical cytology tests and HR-HPV screenings at six and twelve months. Researchers will assess the clearance rates of HR-HPV infections, changes in cytology results, and safety by tracking any adverse events. The total study duration spans up to 72 months, including up to 60 months for patient recruitment and 12 months for follow-up after treatment completion.