Human Papillomavirus Infection
Conditions
Keywords
HPV, sexually-transmitted infection, high-risk HPV, CIN
Brief summary
This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed. Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.
Interventions
DRUGABI-2280
Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Sponsors
Antiva Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind masking
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For sentinel cohorts: Incidence and Severity of Adverse Events | Week 24 | For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo |
| For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline | Week 12 | Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events | Week 24 | For fully expanded cohorts, including sentinel: for each dose/dosing regimen, incidence and severity of AEs, relationship of AEs to IP, and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. |
| Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders | Week 24 | For fully expanded cohorts, including sentinel: For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 24 |
Countries
Australia, Kenya, Mexico, New Zealand
Outcome results
None listed