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

NCT00428285

CompletedPhase 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Conditions: Anus Neoplasms, HIV Infections

Interventions: Argon Plasma Coagulation

Countries: Canada

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).

Eligibility overview

Sex: MALE

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (2)

Montreal, Quebec, Canada
Montreal, Quebec, Canada