AMC 088: A Randomized, Phase III Study of Intra-anal Imiquimod 2.5% vs. Topical 5-fluorouracil 5% vs. Observation for the Treatment of High-grade Anal Squamous Intraepithelial Lesions in HIV-infected Men and Women

The purpose of this study is to assess the efficacy of 2 different topical creams on HSIL.  UCSF will enroll about 20 people in this study. Participants are screened with an HRA along with anal biopsies of anything suspicious for HSIL. Those with HSIL are enrolled in the study and randomized to either a group that receives Imiquimod cream, a group that receives Effudex cream, or a group that does not receive treatment.  The creams are self-applied at home following instructions from the clinicians. Study visits are approximately every 2 weeks. The study lasts just under a year, and anyone with remaining lesions can be treated after the study's completion.

This study is open to HIV positive people of all genders and ages. People who have used these creams previously are excluded.

Contact Information:

Rachel Silverstein

Phone: 415-353-7443

Email: rachel.silverstein@ucsf.edu