This purpose of this study is to test a new way to treat abnormal tissue in the skin near the anus. This abnormal tissue is also called high-grade perianal dysplasia or HSIL. The standard treatment is an operation during which subjects must be under general anesthesia. Subjects who have this surgery are at risk for bleeding and infection. Most subjects have pain for about 3 weeks. Healing may not be perfect and some subjects will leak stool. We are testing a new way of treating HSIL using a cream called cidofovir, which fights certain viruses. Cidofovir made into a cream or gel appears to be effective in treating genital warts which are caused by the human papillomavirus (HPV). HSIL is also caused by HPV.

Inclusion Criteria:

• Men and women 18 years or older with documented HIV infection
• Biopsy proven perianal HSIL within 12 weeks of entry
• Negative pregnancy test and practicing adequate birth control to prevent pregnancy while receiving treatment and for 3 months after treatment is discontinued
• Men must practice adequate birth control to prevent pregnancy while receiving treatment and for 3 months after treatment is discontinued
• Subjects must be:
  • On stable antiretroviral therapy for at least 12 weeks prior to enrollment or
  • If not on HAART, have a CD4 count above 200 and either be receiving no antiretroviral therapy or a non-HAART antiretroviral regimen with no plans to initiate HAART in the next 12 weeks.

Exclusion criteria:

• Currently pregnant or breastfeeding
• Opportunistic infection other than oral thrush, yeast vaginitis, or genital herpes within 14 days of enrollment
• Treatment for an infection (other than oral thrush, yeast vaginitis or genital herpes) or other serious illness within 14 days of study entry
• Untreated invasive cancer of the lower genital tract

This study is being conducted by Dr. Ronald Mitsuyasu under IRB #07-09-076-01

If you think you might be interested in participating in this study, please contact Blanca Corea at 310-557-9062 or email at bcorea@mednet.ucla.edu

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