Anus Neoplasms, HIV Infections
Conditions
Keywords
Human Papilloma Virus, HIV infected MSM, Treatment Experienced, Treatment Naive, Anal Intraepithelial Neoplasia
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.
Interventions
PROCEDUREArgon 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.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Centre/Research Institute of the McGill University Health Centre
CIHR Canadian HIV Trials Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High grade dysplasia (AIN 2/3) | at 1 and 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Anal human papilloma virus (HPV) | at 1 and 2 years |
| Tolerability and safety of the treatment | 2 years |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAlexandra de Pokomandy, MD
Centre hospitalier de l'Université de Montréal (CHUM)
PRINCIPAL_INVESTIGATORGeorge Ghattas, MD
McGill University Health Center and Centre Hospitalier de l'Université de Montréal (CHUM)
Outcome results
None listed