Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

Launched by ANTIVA BIOSCIENCES · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ABI-2280, which comes in the form of vaginal inserts, for women who have been diagnosed with a persistent high-risk HPV infection. The goal is to see if this treatment can help clear the virus and how safe it is for patients. The study will involve several groups of participants, with each group starting with a small number of women. Depending on the results, more participants may be added to help gather more information about the treatment.

To be eligible for this study, women need to be between 25 and 55 years old and must have had positive results for high-risk HPV on at least two tests, along with a medical check-up confirming their condition within the last six months. However, women with a history of more severe cervical issues, certain medical conditions that affect the immune system, or those with a current or past diagnosis of cervical cancer cannot participate. Participants will have the chance to contribute to important research that could help improve treatments for HPV, and they can expect to be closely monitored for safety and effectiveness throughout the study.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • Female sex, 25 to 55 years of age
• • Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
• • Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.
• • Exclusion Criteria
• • History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
• • Any clinically significant immune suppressing condition
• • History or current diagnosis of cervical cancer, suspected or confirmed
• • Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.