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

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

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)

NCT03677960•Antiva Biosciences

View on ClinicalTrials.gov

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

Eligibility

Age

27 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Research Center

Chicago, Illinois, United States

Research Center

Darlinghurst, Sydney, Australia

Key Dates

Start Date

December 17, 2018

Primary Completion Date

June 30, 2019

Completion Date

June 30, 2019

Last Updated

July 24, 2019

Enrollment

ACTUAL participants

Conditions

HSIL, High-Grade Squamous Intraepithelial LesionsHuman Papilloma Virus InfectionHIV InfectionAnal CancerAnus Neoplasm

Interventions

Topical ABI-1968 cream

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITING

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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