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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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)
ClinicalTrials.gov Identifier:
NCT00428285
First received: January 25, 2007
Last updated: March 14, 2013
Last verified: March 2013

January 25, 2007
March 14, 2013
February 2007
February 2010   (final data collection date for primary outcome measure)
High grade dysplasia (AIN 2/3) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
High grade dysplasia (AIN 2/3) at 1 and 2 years
Complete list of historical versions of study NCT00428285 on ClinicalTrials.gov Archive Site
  • Anal human papilloma virus (HPV) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]
  • Tolerability and safety of the treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Anal HPV at 1 and 2 years
Not Provided
Not Provided
 
Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
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

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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anus Neoplasms
  • HIV Infections
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.
Experimental: Single Arm
Intervention: Procedure: Argon Plasma Coagulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
June 2015
February 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00428285
CTN-216, SL06-0.11 (CHUM)
Yes
Alexandra de Pokomandy, Centre hospitalier de l'Université de Montréal (CHUM)
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)
Centre hospitalier de l'Université de Montréal (CHUM)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP