Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions (ANCHOR)
The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer.
The ANCHOR Data Safety Monitoring Board (DSMB) determined that the primary study endpoint was completed, based on the data and statistical analysis presented to them on 07SEP2021.
In the post-randomization phase of this trial, all enrolled participants are offered treatment for HSIL and/or follow-up, at the participant's choice.
DURATION: September 2014 - August 2021
STUDY TYPE: HIV & Cancer
DESIGN: Randomized, parallel assigned, open-label, interventional study
POPULATION: People living with HIV, 35 years of age and older
NUMBER OF SITES: 25
SITE LOCATIONS: US
NCT #: NCT02135419