Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
Anal Dysplasia, Human Papilloma Virus, HIV
About this trial
This is an interventional treatment trial for Anal Dysplasia focused on measuring anal dysplasia, HPV, HIV, MSM
Eligibility Criteria
Inclusion Criteria:
- Male gender, ≥18 years of age
- HIV-infected and taking ARVs with suppressed HIV VL (<48 copies/mL) on 2 consecutive measurements within the previous 6 months
- Any CD4 count will be considered appropriate for study
- Plasma INR < 1.5
- Plasma partial thromboplastin time (PTT) < 35s
- Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500
- Blood hemoglobin > 10.0 g/dL
- Blood platelet count > 50x103/mm3
- Serum total bilirubin < 6.0 mg/dL (subjects taking atazanavir-based ARV regimens may have elevated total bilirubin but are generally < 6)
- Blood aspartate aminotransferase (AST) < 100 U/L (<2 ULN)
- Blood alanine aminotransferase (ALT) < 130 U/L (<2 ULN)
- Serum creatinine < 1.5 mg/dL
- ECOG performance status < 3
- Tricare beneficiary
Exclusion Criteria:
- History of AIN
- Anal canal condyloma requiring surgical treatment
- Anal cancer (current or history of)
- History of prior anal surgery, including hyfrecation, excision, cryotherapy, photocoagulation
- Use of anticoagulants (warfarin, heparin, Pradaxa)
- Inability to attend study visits
- Participation in any other drug study
Sites / Locations
- NMCSD
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
imiquimod
ablative
Observation
i. Each subject will use an imiquimod anal suppository three times weekly (overnight on Monday, Wednesday, Friday) for 12 weeks. ii. Each subject will be asked to abstain from receptive anal sex during therapy period (12 weeks). iii. If local imiquimod adverse effects are severe, a 7-day period off of treatment will be permitted. iv. During 12 week therapy period, each subject will be evaluated 2, 4, 8, and 12 weeks after starting therapy. At each visit, subject will complete a therapy questionnaire and undergo anal Pap, HRA with biopsies as indicated, and anal HPV testing. v. After therapy completed (12 weeks), subject will enter 12 month observation period.
i. Subject will be referred to colorectal surgeon, will complete a therapy questionnaire, and will be treated in accordance with treatment algorithm which is already in use. ii. Subject will be asked to abstain from receptive anal sex for 12 weeks after ablative therapy. iii. After therapy, subject will enter 12 month observation period.
i. Given lack of accepted guidelines and outcome data on dysplasia management, the study PI will thoroughly discuss risks and benefits of observation/monitoring and treatment of dysplasia. ii. If treatment is chosen, subject will be randomized to 1) ablative group, or 2) imiquimod group and begin therapy. Observation subjects will continue observation visits (observation questionnaire, anal Pap, HRA with biopsies as indicated, and anal HPV testing) every 3 months for 12 months (4 additional study visits).