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

Sex: Male

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 20

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

Location: Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal) Montreal Quebec

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 with men (MSM).

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00428285). StuddyBuddy aggregates publicly available trial information.