Clinical Trials


Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men

This study has been completed
Centre hospitalier de l'Université de Montréal (CHUM)

McGill University Health Center
CIHR Canadian HIV Trials Network

Information provided by (Responsible Party)
Alexandra de Pokomandy, Centre hospitalier de l'Université de Montréal (CHUM) Identifier

First received: January 25, 2007
Last updated: July 29, 2016
Last Verified: July 2016
History of Changes


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).

Condition Intervention Phase
Anus Neoplasms
HIV Infections

Procedure : Argon Plasma Coagulation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Alexandra de Pokomandy, Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures

  • High grade dysplasia (AIN 2/3) [ Time Frame: at 1 and 2 years ]
Secondary Outcome Measures:
  • Anal human papilloma virus (HPV) [ Time Frame: at 1 and 2 years ]
  • Tolerability and safety of the treatment [ Time Frame: 2 years ]

Enrollment: 20
Study Start Date: February 2007
Study Completion Date: July 2016
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Single Arm

Procedure: Argon Plasma Coagulation

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.

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.



Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  


Inclusion Criteria:

  • Age 18-65 years
  • The last two High Resolution Anoscopies (HRA) of the patient, occurring at least 4 months apart, revealed histologic diagnoses of AIN 2 or 3
  • HIV infected for at least 6 months
  • Patient must be a man having sex with other men (currently or anteriorly).
  • Able to provide a signed and dated Research Ethics Board (REB)-approved informed consent form (ICF) for the study

Exclusion Criteria:
  • History of invasive anal cancer
  • International normalized ratio (INR) > 1.5
  • Platelet count < 50,000
  • Previously (or currently) received chemotherapy or radiotherapy for AIN or anal cancer
  • Currently receiving interferon or cidofovir treatment
  • Diagnosed with circumferential (diffuse) high-grade AIN, or involving > 75% of the
anal canal.

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00428285


Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal)
Montreal, Quebec, Canada, H2L 4M1
Royal Victoria Hospital (McGill University Health Center)
Montreal, Quebec, Canada, H2X 2P4

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Center
CIHR Canadian HIV Trials Network


Principal Investigator: Alexandra de Pokomandy, MD Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator: George Ghattas, MD McGill University Health Center and Centre Hospitalier de l'Université de Montréal (CHUM)
More Information

More Information

Responsible Party: Alexandra de Pokomandy, MD, Centre hospitalier de l'Université de Montréal (CHUM) Identifier: NCT00428285   History of Changes  
Other Study ID Numbers: CTN-216  
  SL06-0.11 (CHUM)  
Study First Received: January 25, 2007  
Last Updated: July 29, 2016  

Keywords provided by Alexandra de Pokomandy, Centre hospitalier de l'Université de Montréal (CHUM):

Human Papilloma Virus
HIV infected MSM
Treatment Experienced
Treatment Naive
Anal Intraepithelial Neoplasia

Additional relevant MeSH terms:
HIV Infections
Carcinoma in Situ
Anus Neoplasms processed this data on July 20, 2018
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