Urological and Genital Diseases
Conditions
Interventions
Vaginal insert
Vaginal Insert
Sponsors
Antiva Biosciences Inc
Eligibility
Sex/Gender
Female
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Fully Expanded Cohorts including Sentinel: 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. | — |
Countries
Kenya
Contacts
Public ContactAnnie Warsi
Executive Medical Director
Outcome results
None listed