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
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • High grade dysplasia (AIN 2/3) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: February 2007
Estimated Study Completion Date: June 2015
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428285

Locations
Canada, Quebec
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
Investigators
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

No publications provided

Responsible Party: Alexandra de Pokomandy, MD, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00428285     History of Changes
Other Study ID Numbers: CTN-216, SL06-0.11 (CHUM)
Study First Received: January 25, 2007
Last Updated: March 14, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Health Canada

Keywords provided by 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
Acquired Immunodeficiency Syndrome
Anus Neoplasms
Neoplasms
HIV Seropositivity
Carcinoma in Situ
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 19, 2014