Anal Cancer, Anus Neoplasm, HIV Infection, HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection
Conditions
Brief summary
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection
Interventions
DRUGTopical ABI-1968 cream
Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29
Sponsors
Antiva Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
27 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male subjects, at least 27 years old. 2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) 3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. 4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (\<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.
Exclusion criteria
1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. 2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. 3. History of cancer involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years 4. History of genital herpes with \> 3 outbreaks per year. 5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL | MAD portion is 84 days | Number of participants with Adverse Events related to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal. | MAD portion is 84 days | Plasma concentrations of ABI-1968 over time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Histopathology of areas with biopsy-proven disease following multiple doses of ABI-1968 Topical Cream. | MAD portion is 84 days | Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology |
Countries
Australia, United States
Outcome results
None listed