Status:
COMPLETED
Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
CIHR Canadian HIV Trials Network
Conditions:
Anus Neoplasms
HIV Infections
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
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...
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 infe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00428285
Start Date
February 1 2007
End Date
July 1 2016
Last Update
May 1 2019
Active Locations (2)
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1
Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal)
Montreal, Quebec, Canada, H2L 4M1
2
Royal Victoria Hospital (McGill University Health Center)
Montreal, Quebec, Canada, H2X 2P4