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 Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03677960
• Other study ID #: ABI-1968-202
• Status: Terminated
• Phase: Phase 1
• Start date: December 17, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: April 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: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 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 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.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasm
• 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:
• Topical ABI-1968 cream
Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Locations

Country	Name	City	State
Australia	Research Center	Darlinghurst	Sydney
United States	Research Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Antiva Biosciences

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Histopathology of areas with biopsy-proven disease following 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	MAD portion is 84 days
Primary	Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL	Number of participants with Adverse Events related to treatment	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	MAD portion is 84 days