Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
Condition: Anus Neoplasms; HIV Infections
MeSH terms: Neoplasms; Anus Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess if argon plasma coagulation (APC) is a safe and well
      tolerated treatment method for anal intraepithelial neoplasia (AIN) grade 2/3 in HIV-positive
      men having sex with men (MSM).
    

Detailed description: 
      HIV infected men having sex with men (MSM) are at increased risk of developing anal cancer
      compared to the general population and the incidence continues to increase despite better
      control of HIV infection with HAART (Highly Active Anti-Retroviral Therapy). The causative
      agent is known to be Human Papilloma Virus infection which can lead to dysplastic changes in
      the anus, detectable by High Resolution Anoscopy with biopsies. The analysis of the abnormal
      tissue can then be graded as Anal Intraepithelial Neoplasia 1 to 3, with AIN 2 or 3
      considered as high grade dysplasia. These lesions are cancer precursors, but the proportion
      of lesions progressing to invasive anal cancer and the time to event are unknown. There is
      currently no recognized treatment to offer as standard of care although it is of general
      belief that treating these lesions, as it is done for women with CIN 2 and 3 (Cervical
      Intraepithelial Neoplasia) could help decrease the number of progressions to invasive anal
      cancer in MSM infected with HIV.

      By experience at our center and results of this technique for other gastrointestinal
      pathologies, we believe Argon Plasma Coagulation (APC) could be a safe, well tolerated and
      efficient treatment of high-grade dysplasia (AIN 2/3) in HIV infected MSM.

      This study will assess the APC treatment in 20 patients, all HIV infected MSM, with
      established AIN 2/3 (as confirmed with their last two anal biopsies, at least 4 months
      apart). Patients will then be followed with regular High Resolution Anoscopies for two years.
      The primary objective is to assess if APC is a safe and well tolerated treatment method for
      AIN 2/3 in HIV-positive MSM. As secondary objectives, the efficacy of APC treatment on AIN
      2/3 lesions in HIV-positive MSM, the number of treatments with APC necessary to obtain
      regression or resolution of AIN 2/3 over two years and the efficacy of APC treatment to
      decrease anal HPV in this population will also be addressed.
    

Intervention name(s): Argon Plasma Coagulation
Intervention type(s): Procedure
Intervention description(s): Argon Plasma Coagulation (APC) is a non-contact electrosurgical technique delivering a high-frequency electrical current through ionized argon gas i.e. the argon plasma. This current produces a zone of coagulation, desiccation, and devitalisation 2-3 mm deep. Patients will be offered up to 3 treatments if recurrence occur after the first two.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Papilloma Virus; HIV infected MSM; Treatment Experienced; Treatment Naive; Anal Intraepithelial Neoplasia