AMC-088: Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

What we are studying

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

Who is Eligible

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

Eligibility Criteria

  • Never been vaccinated against HPV
  • Must not be pregnant and must agree not to become pregnant during the study
  • No prior HSIL treatment
  • No condylma treatment in the past 6 months
  • Must have HSIL present (we will determine this)
  • HIV positive

What is involved

  • Visits to the clinic for screening and then 10 visits over the next 11 months at which time study is completed
  • Blood draws
  • Anal swabs
  • Pregnancy tests
  • Study procedure (High Resolution Anoscopy)
  • Application of cream
  • Questionnaires

Compensation

You will be paid $40 for each visit until study completion

Contact Information

Study Coordinator
Keisa Williamson
Email
keiwilli@wakehealth.edu
Phone
336-716-8918
Principal Investigator
Luis F. Barroso, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.