Clinical trial NCT00428285: Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anus Neoplasms
HIV Infections
Keywords: Human Papilloma Virus
HIV infected MSM
Treatment Experienced
Treatment Naive
Anal Intraepithelial Neoplasia
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: CIHR Canadian HIV Trials Network
First posted: 2007-01-29
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 with men (MSM).

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.

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.

Primary outcomes:
measure: High grade dysplasia (AIN 2/3)
timeFrame: at 1 and 2 years
Secondary outcomes:
measure: Anal human papilloma virus (HPV)
timeFrame: at 1 and 2 years
measure: Tolerability and safety of the treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal)
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital (McGill University Health Center)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Alexandra de Pokomandy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Center and Centre Hospitalier de l'Université de Montréal (CHUM)
name: George Ghattas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Pokomandy A, Rouleau D, Lalonde R, Beauvais C, de Castro C, Coutlee 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 have sex with men living with HIV: results of a 2-year prospective pilot study. HIV Med. 2018 Feb;19(2):81-89. doi: 10.1111/hiv.12544. Epub 2017 Aug 23.