Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions

Summary

The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer.

The ANCHOR Data Safety Monitoring Board (DSMB) determined that the primary study endpoint was completed, based on the data and statistical analysis presented to them on 07SEP2021.

In the post-randomization phase of this trial, all enrolled participants are offered treatment for HSIL and/or follow-up, at the participant's choice.

Conditions

• Anal Cancer
• High-grade Squamous Intraepithelial Lesion
• HIV Infection
• Human Papilloma Virus Infection

Interventions

DRUG

imiquimod

Applied topically

DRUG

fluorouracil

Applied topically

DEVICE

infrared photocoagulation therapy

Undergo infrared coagulation

DEVICE

thermal ablation therapy

Undergo hyfrecation/electrocautery therapy

DEVICE

laser therapy

Undergo laser therapy

OTHER

clinical observation

Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• University of Arkansas

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• AIDS Malignancy Consortium

  lead NETWORK

Principal Investigators

• Joel Palefsky, MD · AIDS Malignancy Consortium

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-24

Primary Completion

2021-08-06

Completion

2024-03-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States
• Puerto Rico

Study Locations