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

April 29, 2019 updated by: Alexandra de Pokomandy, Centre hospitalier de l'Université de Montréal (CHUM)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
High grade dysplasia (AIN 2/3)
Time Frame: at 1 and 2 years
at 1 and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Anal human papilloma virus (HPV)
Time Frame: at 1 and 2 years
at 1 and 2 years
Tolerability and safety of the treatment
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN-216
  • SL06-0.11 (CHUM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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