Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Stopped early · Phase 1
Conditions studied: HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasm
In brief
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
Key facts
- Study ID
- NCT03677960
- Run by
- Antiva Biosciences
- People needed
- 6
- Starts
- 2018-12-17
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2019-07-24
Who can join
Age: 27 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female or male subjects, at least 27 years old.
- Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
- Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
- 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.
You may not qualify if…
- Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
- Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
- 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
- History of genital herpes with > 3 outbreaks per year.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
Where it is running
- Research Center — Chicago, Illinois, United States
- Research Center — Darlinghurst, Sydney, Australia
Full record on ClinicalTrials.gov
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