Trial Information

A Phase II, Prospective, Open-label, Pilot Study of the Tolerability, Safety, and Efficacy of Argon Plasma Coagulation for the Treatment of Anal Intraepithelial Neoplasia Grade 2 or 3 in HIV-positive Men Having Sex With Men

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.