Human papillomavirus (HPV) viral load and HPV type in the clinical outcome of HIV-positive patients treated with imiquimod for anogenital warts and anal intraepithelial neoplasia

J Eur Acad Dermatol Venereol. 2007 Sep;21(8):1054-60. doi: 10.1111/j.1468-3083.2007.02169.x.


Objective: To evaluate the efficacy of 5% imiquimod in HIV-positive male patients with anogenital warts or anal intraepithelial neoplasia (AIN), and to elucidate whether human papillomavirus (HPV) type and viral load were important for clinical outcome and recurrences.

Methods: Thirty-seven patients with histologically proven anogenital warts or AIN were enrolled. Topical 5% imiquimod was applied three times per week for more than 8 h overnight for 16 weeks, although patients were allowed to continue therapy for 4 more weeks if they did not have complete clearance of lesions.

Results: Mean age was 34 years. The perianal area was the main lesion location. Thirty-three patients had CD4 counts of < 500 cells/mm(3). Eighteen patients had a histopathological diagnosis of AIN-1. Main HPV types detected corresponded to low-risk HPV types. At 20 weeks of therapy, 46% patients achieved total clearance whereas 14 patients had > 50% clearance. Recurrence was observed in 5 of 17 patients who cleared. Clearance was not influenced by patients' CD4 counts, wart location, HIV viral load or HPV viral load.

Conclusions: The assumption that visible perianal warts are benign lesions in HIV-positive patients has to be reevaluated since an important number of such lesions could correspond to low-grade anal disease, which in turn could progress to high-grade anal disease or cancer. In addition, our results in this preliminary study indicate that imiquimod appears to be effective in treating AIN in HIV-positive patients. Further studies are needed to document its utility to prevent high-grade dysplasia and/or anal cancer.

Publication types

  • Clinical Trial

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • AIDS-Related Opportunistic Infections / virology
  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / therapeutic use*
  • Administration, Topical
  • Adult
  • Aminoquinolines / administration & dosage
  • Aminoquinolines / therapeutic use*
  • Anus Diseases / drug therapy*
  • Anus Diseases / virology
  • Anus Neoplasms / drug therapy*
  • Anus Neoplasms / virology
  • Carcinoma in Situ / drug therapy
  • Carcinoma in Situ / virology
  • Condylomata Acuminata / drug therapy*
  • Condylomata Acuminata / virology
  • Genital Diseases, Male / drug therapy*
  • Genital Diseases, Male / virology
  • Humans
  • Imiquimod
  • Male
  • Middle Aged
  • Papillomaviridae / classification
  • Papillomavirus Infections / drug therapy*
  • Papillomavirus Infections / virology
  • Polymerase Chain Reaction
  • Treatment Outcome
  • Viral Load


  • Adjuvants, Immunologic
  • Aminoquinolines
  • Imiquimod