Background: HIV-positive patients have unpredictable local immune responses even with severe systemic immunosuppression and data reported to date is insufficient to predict the effect of imiquimod in HIV-positive patients.
Objective: To evaluate the efficacy of 5% topical imiquimod in HIV-positive male patients with anogenital warts (AGW) and to elucidate its effect on recurrence.
Study design: Open-label clinical trial.
Results: Of the 43 patients enrolled, 86% completed treatment. Patients' mean age was 34 years (range: 19-50). Thirty-one patients were receiving highly active antiretroviral therapy (HAART) therapy. At week 16, 10 patients completely cleared lesions and 21 patients had a wart size reduction > or =50%. At 20 weeks of therapy, 17 patients achieved total clearance whereas 14 patients had a >50% wart reduction. Clearance was not influenced by CD4-counts, HIV-viral load, previous therapy, or wart localization. Of the patients who experienced a complete clearance, five (29%) had a recurrence. Mean time of recurrence was 14.4 weeks. Erythema, pruritus, and burning sensation were the most frequent local skin reactions.
Conclusions: Topical 5% imiquimod is safe and may benefit HIV-positive patients with anogenital warts particularly when it is used for up to 20 weeks. It is also useful to decrease wart recurrence.