Clinical trial · Interventional
Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
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
NCT00428285CI-TRIAL-00122149completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Argon Plasma Coagulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Procedure: Argon Plasma Coagulation
Primary outcomes (1)
- measure
- High grade dysplasia (AIN 2/3)
- timeFrame
- at 1 and 2 years
Secondary outcomes (2)
- measure
- Anal human papilloma virus (HPV)
- timeFrame
- at 1 and 2 years
- measure
- Tolerability and safety of the treatment
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTde 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. PMID 28833949