Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts (ABI-2280-401)
- Conditions
- Urological and Genital Diseases
- Registration Number
- PACTR202408538482330
- Lead Sponsor
- Antiva Biosciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 160
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For Sentinel Cohorts: Incidence and Severity of Adverse Events for each dose/dosing regimen.;Fully Expanded Cohorts including Sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline.
- Secondary Outcome Measures
Name Time Method Fully Expanded Cohorts including Sentinel: Incidence and Severity of Adverse Events for each dose/dosing regimen.<br>;Fully Expanded Cohorts including Sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline.