Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

Completed · Phase 1

Conditions studied: HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasms

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: NCT03202992
Run by: Antiva Biosciences
People needed: 57
Starts: 2017-08-11
Expected to finish: 2019-02-04
Last updated by the study team: 2019-02-07

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, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
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 — San Francisco, California, United States
Research Center — Orlando, Florida, United States
Research Center — Chicago, Illinois, United States
Research Center — New York, New York, United States
Research Center — Winston-Salem, North Carolina, United States
Research Center — Sydney, Darlinghurst, Australia

Full record on ClinicalTrials.gov

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