Summary

for people ages 27 years and up (full criteria)
at UCSF
study started
estimated completion:

Description

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.

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)

Keywords

HSIL, High-Grade Squamous Intraepithelial Lesions Human Papilloma Virus Infection HIV Infection Anal Cancer Anus Neoplasms Infection Communicable Diseases HIV Infections Virus Diseases Papilloma Squamous Intraepithelial Lesions of the Cervix Papillomavirus Infections ABI-1968 Dose 1 -Single Ascending Dose (SAD) Dose 2 -Single Ascending Dose (SAD) Dose 3 -Single Ascending Dose(SAD) Dose 4 -Single Ascending Dose(SAD) Dose 5 -Single Ascending Dose(SAD) Dose 1 - Multiple Ascending Dose(MAD) Dose 2 -Multiple Ascending Dose(MAD) Dose 3 -Multiple Ascending Dose(MAD) Dose 4-Multiple Ascending Dose(MAD)

Eligibility

You can join if…

Open to people ages 27 years and up

  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.

You CAN'T join if...

  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.

Locations

  • Research Center
    San Francisco California 94115 United States
  • Research Center
    Chicago Illinois 60614 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Antiva Biosciences
ID
NCT03202992
Phase
Phase 1
Study Type
Interventional
Last Updated