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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428285
• Other study ID #: CTN-216
• Secondary ID: SL06-0.11 (CHUM)
• Status: Completed
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: July 2016

Study information

• Verified date: April 2019
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anus Neoplasms
• Carcinoma in Situ
• HIV Infections
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal)	Montreal	Quebec
Canada	Royal Victoria Hospital (McGill University Health Center)	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	CIHR Canadian HIV Trials Network, McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (1)

de Pokomandy A, Rouleau D, Lalonde R, Beauvais C, de Castro C, Coutlée F; Human Immunodeficiency and Papilloma Virus Research Group (HIPVIRG) Study Group. Argon plasma coagulation treatment of anal high-grade squamous intraepithelial lesions in men who ha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High grade dysplasia (AIN 2/3)		at 1 and 2 years
Secondary	Anal human papilloma virus (HPV)		at 1 and 2 years
Secondary	Tolerability and safety of the treatment		2 years