title: Imiquimod treatment of anal intraepithelial neoplasia in HIV-positive men.
abstract: 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).
  
  
  METHODS
  Prospective, nonrandomized, open-label pilot study, with a mean follow-up time of 9(1/2) months.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Institute of Virology, University of Cologne, Cologne, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Wieland
authors.forename: Norbert H
authors.initials: NH
authors.lastname: Brockmeyer
authors.forename: Soenke J
authors.initials: SJ
authors.lastname: Weissenborn
authors.forename: Bettina
authors.initials: B
authors.lastname: Hochdorfer
authors.forename: Markus
authors.initials: M
authors.lastname: Stücker
authors.forename: Jochen
authors.initials: J
authors.lastname: Swoboda
authors.forename: Peter
authors.initials: P
authors.lastname: Altmeyer
authors.forename: Herbert
authors.initials: H
authors.lastname: Pfister
authors.forename: Alexander
authors.initials: A
authors.lastname: Kreuter
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001005:Anus Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D004279:DNA, Viral / Q000032:analysis; D015658:HIV Infections; D018451:Homosexuality, Male; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000150:complications; D010865:Pilot Projects; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D013488:Suppositories; D016896:Treatment Outcome
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D004279:DNA, Viral; D013488:Suppositories; D000077271:Imiquimod