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

HIV Infection Clinical Trial

Official title:

Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202992
• Other study ID #: ABI-1968-201
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2017
• Est. completion date: February 4, 2019

Study information

• Verified date: February 2019
• Source: Antiva Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Years and older

Eligibility

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, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.

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.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Communicable Diseases
• HIV Infection
• HIV Infections
• HSIL, High-Grade Squamous Intraepithelial Lesions
• Human Papilloma Virus Infection
• Infection
• Papilloma
• Papillomavirus Infections
• Squamous Intraepithelial Lesions of the Cervix
• Virus Diseases

Intervention

Drug:
• ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Locations

Country	Name	City	State
Australia	Research Center	Sydney	Darlinghurst
United States	Research Center	Chicago	Illinois
United States	Research Center	New York	New York
United States	Research Center	Orlando	Florida
United States	Research Center	San Francisco	California
United States	Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Antiva Biosciences

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL	Number of participants with Adverse Events related to treatment	SAD portion is 29 days/MAD portion is 84 days
Secondary	Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.	Plasma concentrations of ABI-1968 over time	SAD portion is 29 days/MAD portion is 84 days
Secondary	Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.	Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology	SAD portion is 29 days/MAD portion is 84 days