AMC 088

AMC-088: A randomized clinical trial of self-applied 5- fluorouracil cream compared to observation alone for the treatment of anal pre-cancers in HIV-positive men and women

AMC-088 will study a drug applied directly to the anal skin, also known as a topical therapy. We want to know if this topical drug is effective at getting rid of anal high-grade squamous intraepithelial lesions (anal HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk of turning into cancer of the anus.

Treating anal HSIL has been shown to lower the risk of developing anal cancer. We also want to understand how well people are able to tolerate this treatment. The treatment is topical 5-fluorouracil (5FU), which is also known as EFUDEX.

Eligibility criteria

  • HIV positive, male or female, ≥ 21 years of age
  • Biopsy-proven anal high-grade squamous intraepithelial lesions (anal HSIL)
  • No History of anal cancer
  • No prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for the treatment of HSIL at any point
  • And more…

Study eligibility & contact

For details about the eligibility criteria please contact Arezou Sadighi Akha:
Tel: 415-353-9042
Email: [email protected]