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

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