Updated on 23 November 2020


This randomized phase III trial compares 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. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer.


Condition Human Papilloma Virus (HPV), Anal Dysplasia
Clinical Study IdentifierTX202587
Last Modified on23 November 2020


Yes No Not Sure

Inclusion Criteria

HIV positive. Documentation of HIV-1 infection by means of any one of the following
Documentation of HIV diagnosis in the medical record by a licensed health care provider
Documentation of receipt of ART by a licensed health care provider
HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL
Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay
Age 35 years or older
Biopsy-proven anal HSIL at baseline
At least one focus of HSIL must be identified that is not within a condyloma that may be treated after enrollment into the study. This requirement is to ensure that there will still be at least one focus of HSIL among participants in the Active Monitoring Arm even if they undergo treatment for condyloma
For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines. Cervical cytology must be performed prior to enrollment for women who are overdue for screening per the guidelines. Women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to enrollment
ECOG performance status < 1 (Karnofsky > 70%)
Life expectancy of greater than 5 years
Participants must meet the following parameters within 90 days before enrollment
Absolute neutrophil count: > 750/mm3
Platelets: > 75,000/mm3
Hemoglobin: > 9.0 g/dL
Women of childbearing potential (FCBP) must have a negative urine pregnancy test within 7 days prior to randomization enrollment. Female participants enrolled in the treatment arm are advised to not become pregnant during study participation due to the risks of the study treatments. All women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued if the participant is enrolled in the treatment arm. Female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the Investigator
A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Men randomized to the treatment arm should not father a baby while receiving topical treatment during this study. Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
Participant is willing to be randomized and able to comply with the protocol
Clinician is comfortable that cancer has adequately been ruled out and is willing to follow the participant for up to 5 years without treatment of the HSIL

Exclusion Criteria

Participant is unable to provide informed consent
Participants who received any other chronic (defined as more than 50% of the time in the last 6 months) systemic immunomodulatory agents (replacement doses of steroids for adrenal insufficiency are permitted or treatment with prednisone .5 mg/day). Receipt of investigational agents within the 4 weeks before randomization enrollment, other than investigational antiretroviral agents for HIV and investigational or approved agents for Hepatitis C, are also exclusionary
History of anal cancer, penile, vulvar, vaginal, or cervical cancer, or signs of any of these malignancies at baseline. Participants with prior carcinoma in situ will not be considered to have prior cancer for eligibility purposes
Treatment or removal of HSIL less than 6 months prior to randomization
Participant has symptoms related to HSIL and would benefit more from immediate treatment than from entry into the study and potential for randomization to active monitoring arm
Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL
Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy
Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
Participant plans to relocate away from the study site to a location that does not have an ANCHOR study site during study participation
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