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Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

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ClinicalTrials.gov Identifier: NCT01164722
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : October 31, 2016
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia

PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how well it works compared to observation in preventing anal cancer in HIV-positive patients with anal neoplasia.

Condition or disease Intervention/treatment Phase
Anal Cancer Neoplasm of Uncertain Malignant Potential Nonneoplastic Condition Precancerous Condition Other: clinical observation Device: infrared photocoagulation therapy Phase 3

Detailed Description:



  • Evaluate the complete response rate at 3 months and 1 year in HIV-seropositive patients with high-grade anal intraepithelial neoplasia (HGAIN) treated with infrared coagulator (IRC) ablation versus observation.


  • Determine the tolerability and safety of IRC ablation versus observation in these patients.
  • Compare the proportion of patients with HGAIN at 1 year.
  • Evaluate the response and recurrence rates at 1 year of individual lesions in patients treated with this regimen vs observation.
  • Determine the incidence of metachronous lesions in these patients.
  • Compare the response and recurrence rates at 2 years of individual lesions in patients under observation who subsequently received IRC ablation with the response and recurrence rates at 1 year in patients initially treated with IRC.

OUTLINE: This is a multicenter study. Patients are stratified according to site. Patients are randomized to 1 of 2 arms.

  • Arm I: Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance for 1.5 seconds. IRC ablation is reapplied until the level of submucosal vessels are reached.

    • One week after each IRC ablation, patients complete a questionnaire regarding pain, bleeding, and other complaints.
  • Arm II: Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions.

NOTE: Patients may receive a maximum of 6 IRC treatments while on study (3 per year).

Patients undergo a physical exam, digital rectal exam, anal cytology, and HRA at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 2 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults
Study Start Date : April 2011
Primary Completion Date : July 2015
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm I: Infrared coagulator treatment
Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
Device: infrared photocoagulation therapy
Anal infrared coagulator ablation
Other Names:
  • Redfield Infrared Coagulator
  • Redfield IRC
Active Comparator: Arm II: Expectant management
Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
Other: clinical observation
Patients undergo observation

Outcome Measures

Primary Outcome Measures :
  1. Complete Response Through 1 Year [ Time Frame: 1 year post treatment ]
    No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.

Secondary Outcome Measures :
  1. Tolerability and Safety of Infrared Coagulator Ablation [ Time Frame: All study visits through year 2 ]
    Number of patients who experienced a serious adverse events

  2. Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year [ Time Frame: 1 year on study ]
    Number of patients who had high grade anal intraepithelial neoplasia at one year.

  3. Recurrence Rate at 1 Year [ Time Frame: 1 year on study ]
  4. Incidence of Metachronous Lesions [ Time Frame: one year on study ]
    Number of patients with one or more metachronous lesions

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of high-grade anal intraepithelial neoplasia (AIN) meeting the following:

    • AIN2 and/or AIN3 confirmed by biopsy ≥ 2 weeks to ≤ 60 days before enrollment
    • 1-3 lesions with each lesion ≤ 15 mm in diameter
    • At least one high-grade AIN lesion is still visible at study entry
  • HIV-infection documented by federally approved, licensed HIV-test in conjunction with screening test (e.g., ELISA, western blot, or other test)

    • HIV-infection, based on prior ELISA and western blot assays, recorded and documented by another physician, allowed provided patient undergoes an approved antibody test to confirm diagnosis
    • Patients on concurrent anti-retroviral therapy with a history of HIV-positivity based on an approved antibody test allowed
    • Detectable plasma HIV-1 RNA also allowed
  • No perianal AIN, perianal condyloma, or lower vulvar intraepithelial neoplasia or condyloma requiring treatment


  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 2 years
  • CD4 count ≥ 200/mm³
  • ANC > 750/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • INR and aPTT normal
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Female patients must have undergone cervical pap smear (if having a cervix) and gynecologic evaluation within the past 12 months
  • Must be capable of complying with the requirements of this protocol
  • Concurrent HPV-related disease allowed
  • No history of anal cancer
  • No acute infection or other serious medical illness requiring treatment within the past 14 days

    • Fungal infection of the skin or a sexually transmitted disease requiring treatment allowed
  • No concurrent malignancy requiring systemic therapy

    • Kaposi sarcoma limited to the skin allowed


  • No prior infrared coagulator (IRC) ablation for high-grade anal intraepithelial neoplasia (HGAIN)

    • Prior HGAIN treated by any means other than IRC within the past 2 months allowed
  • At least 5 days since prior coumadin or clopidogrel and ≥ 7 days after study therapy before receiving coumadin or clopidogrel again
  • No concurrent anticoagulant therapy other than aspirin or NSAIDs
  • More than 3 months since prior and concurrent systemic corticosteroids, cytokines, or immunomodulatory therapy (e.g., interferons) or local imiquimod
  • No concurrent systemic therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164722

United States, California
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90095-1793
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, New York
Laser Surgery Care
New York, New York, United States, 10010
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
University of Arkansas
Principal Investigator: Stephen E. Goldstone, MD Laser Surgery Care
More Information

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT01164722     History of Changes
Other Study ID Numbers: AMC-076
U01CA121947 ( U.S. NIH Grant/Contract )
AMC-076 ( Other Identifier: AMC )
First Posted: July 19, 2010    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: February 13, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AIDS Malignancy Consortium:
anal cancer
HIV infection
human papilloma virus infection
neoplasm of uncertain malignant potential
high-grade squamous intraepithelial lesion

Additional relevant MeSH terms:
Anus Neoplasms
Precancerous Conditions
Pathologic Processes
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases