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Ulrike Wieland, MD; Norbert H. Brockmeyer, MD; Soenke J. Weissenborn, PhD; Bettina Hochdorfer, MD; Markus Stücker, MD; Jochen Swoboda, MD; Peter Altmeyer, MD; Herbert Pfister, PhD; Alexander Kreuter, MD; for the Competence Network HIV/AIDS

Arch Dermatol. 2006;142:1438-1444.

Objective  To evaluate the treatment of anal intraepithelial neoplasia (AIN) with the local immune response modifier imiquimod in human immunodeficiency virus (HIV)-positive men who have sex with men (MSM).

Design  Prospective, nonrandomized, open-label pilot study, with a mean follow-up time of 9 months.

Setting  Dermatology department of a university hospital.

Patients  Twenty-eight consecutive HIV-positive MSM with histologically confirmed perianal (n = 23) or intra-anal (n = 5) AIN.

Intervention  Overnight treatment with self-applied imiquimod cream (perianal AIN) or suppositories (intra-anal AIN) 3 times a week for 16 weeks.

Main Outcome Measures  Response to treatment was documented using clinical, cytologic, and histologic criteria. Human papillomavirus (HPV) typing and HPV DNA load determination for the high-risk HPV types 16, 18, 31, and 33 were performed.

Results  Seventeen (61%) of all 28 patients included in the study and 17 (77%) of the 22 patients with AIN, who applied imiquimod as instructed, showed clinical and histologic clearance at the end of therapy. Four patients had residual AIN and 1 patient did not improve. Clinical response was accompanied by a sharp decline in HPV DNA loads and by a reduction in the number of HPV types, but long-term HPV clearance was rarely achieved. In the follow-up period, AIN cleared in 3 patients with residual AIN. Fourteen (78%) of 18 imiquimod responders with at least 5 five months of follow-up had a normal cytologic and clinical picture at the end of the follow-up period. Three primary responders developed a recurrence. In 6 noncompliant patients, there was no clinical or morphological improvement and the HPV DNA loads remained high.

Conclusions  Imiquimod appears to be a safe and effective treatment option for AIN in HIV-positive MSM. Clinical response is accompanied by a significant decrease in high-risk HPV DNA load. These results should encourage controlled randomized studies of imiquimod treatment of AIN.

Trial Registration  clinicaltrials.gov Identifier: NCT00365729

Author Affiliations: Institute of Virology, University of Cologne, Cologne (Drs Wieland, Weissenborn, and Pfister), Department of Dermatology and Allergology, Ruhr University Bochum, Bochum (Drs Brockmeyer, Hochdorfer, Stücker, Altmeyer, and Kreuter), and Institute of Cytology, Godesberg (Dr Swoboda), Germany.
Group Information: A list of the Competence Network HIV/AIDS members appears at www.kompetenznetz-hiv.de.

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