The AIDS Malignancy Consortium
is a National Cancer Institute-supported clinical trials group focused on HIV-associated and AIDS-defining cancers. Human Papillomavirus (HPV) is the most common sexually transmitted disease, infecting at least 75% of sexually active adults at some point in their lifetime. HPV causes most of the cancers of the anus and cervix, many head & neck cancers, as well as other cancers. There are limited therapeutic options for treatment of anal high-grade anal squamous intraepithelial lesions (HSIL), particularly intra-anal HSIL. There are no data available on daily application of imiquimod 2.5% (ZyclaraR
) for treatment of anal HSIL. This multisite, randomized study seeks to determine the efficacy of treatment using imiquimod 2.5% compared to observation and the efficacy of treatment
using 5-fluorouracil 5% (EffudexR
) compared to observation in HIV-infected individuals with high resolution anoscopy (HRA)-guided biopsy-proven intra-anal HSIL. AMC-088: Self-applied Imiquimod Gel or 5-fluorouracil Cream to Observation alone for the Treatment of Anal pre-cancers in HIV-infected Men and Women (More Information)
This study will compare two study drugs that are applied directly to the anal skin, also known as topical therapy. We want to know if these topical drugs are effective at getting rid of anal HSIL. Basic Trial Eligibility:
- Must be 25 years old or older
- Must have proven HIV-1 infection
- Must have biopsy-proven high-grade anal intraepithelial lesions (AIN2 and/or AIN3) occupying >25% of the circumference of the anal canal
- Must not have lesions suspicious for invasive cancer
- Must not have extensive concurrent perianal or lower vulvar HSIL or condyloma requiring a different treatment modality
On behalf of the AMC-088 study team, we welcome your interest and questions.
Thank you for considering this important study for your patients.
|Timothy Wilkin, MD|