AMC-088: A Study of Intra-anal Imiquimod vs. Topical 5-fluorouracil vs. Observation for the Treatment of High-grade Anal Squamous Intraepithelial Lesions for HIV-positive Men and Women

What we are studying

The purpose of this study is to see if a topical cream (either 5-FU or imiquimod) can treat High-grade squamous intraepithelial lesions (HSIL) (a type of precancerous lesions) in the anus safely and effectively in HIV positive individuals.

Who is Eligible

  • All Genders
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 25+

Eligibility Criteria

  • Diagnosed with HIV/AIDS
  • Not Pregnant
  • No History of Anal Cancer
  • Further Criteria Will Be Discussed with Study Team

What is involved

  • Informed Consent Review
  • Review of Medical History
  • Physical Examinations
  • Phone Calls and/or Emails
  • Study Visits and Consultations
  • Surveys/Questionnaires
  • Laboratory and Imaging Tests
  • Specimen Sample Collection
  • Use of Study Treatments or Placebo


Yes. The amount will be discussed with the study team.

Contact Information

Study Coordinator
Elizabeth Zieser-Misenheimer
[email protected]
(336) 716-5685
Principal Investigator
Luis F. Barroso, MD

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