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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer, Infectious Disease, HIV / AIDS, HIV / AIDS, Women's Studies, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/30/2018
Start Date:December 2013
End Date:June 2019

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Screening HIV-Infected Women for Anal Cancer Precursors

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.

PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of HPV testing using different methods of
detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays
(APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening
performance of routine anal cytology for the detection of anal high-grade squamous
intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL.

II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women.

III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years
among HIV infected women undergoing semi-annual anal evaluations.

SECONDARY OBJECTIVES:

I. To evaluate the acceptability of anal cancer screening among HIV-infected women.

II. To collect data on quality of life and health care costs (including non-direct health
care costs and time costs) for an economic evaluation of the cost-effectiveness of anal
cancer screening strategies in HIV-positive women.

OUTLINE:

Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture
2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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New York, New York 10011
Principal Investigator: Stephen Goldstone, M.D.
Phone: 212-242-6500
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Ayad Hamdan, MD
Phone: 617-667-2153
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Elizabeth Y. Chiao
Phone: 713-873-4105
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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72 East Concord St.
Boston, Massachusetts 02118
617-638-4173
Principal Investigator: Elizabeth Stier, MD
Phone: 617-414-5175
Boston University Cancer Research Center
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Chicago, Illinois 60612
Principal Investigator: Paul Rubinstein, MD
Phone: 312-864-5204
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Los Angeles, California 90095
Principal Investigator: Ronald Mitsuyasu, MD
Phone: 301-557-3729
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New York, New York 10021
Principal Investigator: Timothy Wilkin, MD, MPH
Phone: 212-746-7163
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Pittsburgh, Pennsylvania 15261
Principal Investigator: Ross Cranston, MD
Phone: 412-383-1434
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San Francisco, California 94115
Principal Investigator: Joel Palefsky, MD
Phone: 415-353-7443
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San Juan, 00927
Principal Investigator: Vivian Tamayo, MD
Phone: 787-772-8300
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Luis Barroso, MD
Phone: 336-716-8918
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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