Malmedy

Researchers are investigating the effect of 2LPAPI4, an immune regulator, on clearing genital high-risk human papillomavirus (HR-HPV) infections. The study focuses on women aged 25 to 45 with diagnosed HR-HPV infections identified during routine cervical cancer screenings. This phase 4, placebo-controlled trial aims to compare 2LPAPI4 to a placebo in terms of clearing these infections, following current guidelines that recommend monitoring rather than immediate treatment after initial detection of HR-HPV. Participants will be divided into two groups: one receiving 2LPAPI4 and the other receiving a placebo, each treated for six months. After the treatment phase, there will be a six-month follow-up to assess infection clearance and cytology results. Treatment success is defined by the elimination of HR-HPV and normalization of cervical cell changes. The study plans to include 284 women, with 142 in each group, and may extend recruitment beyond 60 months if needed. During the study, participants will undergo cytology tests and HPV typing at baseline, six months, and twelve months. Researchers will monitor infection clearance rates, cytological changes, and any adverse events related to the treatment. Participants must be able to maintain a stable sexual relationship and comply with study requirements for the full 12-month duration. Safety and effectiveness data will be collected throughout the study to understand better how 2LPAPI4 may impact HR-HPV infections.