Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
Status:
Withdrawn
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Context:
Men who have sex with men (MSM) are at increased risk for HPV-related anal neoplasia and anal
squamous cell carcinoma; concomitant HIV infection roughly doubles that risk.
Objectives:
1. To compare the efficacy of ablative therapy to topical imiquimod therapy in the
management of anal dysplasia in HIV-infected men.
2. To describe relationship between cytologic grade of anal dysplasia (as reported on
screening anal Pap test) and pathologic grade reported on anal mucosa histopathologic
examination.
3. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of
anal dysplasia.
4. To describe adverse effects associated with ablative therapy and topical imiquimod
therapy.
Design:
Prospective, randomized controlled clinical trial. This will be a pilot study. All subjects
will undergo baseline anal Pap, HRA with biopsies as indicated, and anal HPV testing. If AIN
2 or 3 is discovered on histopathologic examination, subject will be offered observation only
or treatment. If he chooses treatment, he will be randomized to: 1) imiquimod anal
suppositories three times weekly for 3 months, or 2) appropriate ablative therapy as
determined by colorectal surgeon. During imiquimod treatment (not applicable to ablative
group as their treatment will be completed in one visit) subjects will be followed for 2
weeks, 4 weeks, 8 weeks, and 12 weeks with anal Pap, HRA with biopsies as indicated, and anal
HPV testing. After therapy completed in each treatment group, subjects will be followed for 1
month, 3 months, 6 months, 9 months, and 12 months post-therapy with anal Pap, HRA with
biopsies as indicated, and anal HPV testing. Observation only subjects will be evaluated
every 3 months with anal Pap, HRA with biopsies as indicated, and anal HPV testing for 12
months. We have chosen a goal of 30 subjects in each treatment group and 10 subjects in the
observation only group based on the likelihood of enrolling a study of this type in a
reasonable amount of time.
Main Outcome Measures:
1. Anal Pap cytologic grade, including regression and recurrence during course of study
2. HPV type in anal canal, including regression and recurrence during course of study
3. Anal histology, including regression and recurrence during course of study
4. Adverse effects experienced during treatment, recorded in symptom log