Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

Completed · Not applicable

Conditions studied: Anal Cancer, HIV Infection, Human Papilloma Virus Infection

In brief

This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.

Key facts

Study ID

NCT01946139

Run by

AIDS Malignancy Consortium

People needed

276

Starts

2013-12-04

Expected to finish

2018-10-31

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
• Karnofsky performance status > 70%
• Absolute neutrophil count >= 750 cells/mm\^3 within 120 days of study entry
• Platelet count >= 75,000 cells/mm\^3 within 120 days of study entry

You may not qualify if…

• Current or history of anal or perianal carcinoma
• History of anal HSIL cytology or histology
• Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
• For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
• Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
• Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS)
• Inability to provide informed consent
• Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia [AIN]) within 4 months of study entry

Where it is running

• UCLA Clinical AIDS Research and Education (CARE) Center — Los Angeles, California, United States
• Ucsf Ancre — San Francisco, California, United States
• John H. Stroger Hospital of Cook County — Chicago, Illinois, United States
• Boston University Cancer Research Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Weill-Cornell Medical College — New York, New York, United States
• Laser Surgery Care Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Puerto Rico Comprehensive Cancer Center — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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