NCT00428285

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

January 25, 2007

Last Update Submit

April 29, 2019

Conditions

Anus NeoplasmsHIV Infections

Keywords

Human Papilloma VirusHIV infected MSMTreatment ExperiencedTreatment NaiveAnal Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

  • High grade dysplasia (AIN 2/3)

    at 1 and 2 years

Secondary Outcomes (2)

  • Anal human papilloma virus (HPV)

    at 1 and 2 years

  • Tolerability and safety of the treatment

    2 years

Study Arms (1)

Single Arm

EXPERIMENTAL
Procedure: Argon Plasma Coagulation

Interventions

Argon Plasma CoagulationPROCEDURE

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.

Single Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal)

Montreal, Quebec, H2L 4M1, Canada

Location

Royal Victoria Hospital (McGill University Health Center)

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28833949RESULT

MeSH Terms

Conditions

Anus NeoplasmsHIV Infections

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, Surgical

Study Officials

  • Alexandra de Pokomandy, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

  • George Ghattas, MD

    McGill University Health Center and Centre Hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2010

Study Completion

July 1, 2016

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

CA(2)