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

AIDS Malignancy Consortium

Status: Completed

Conditions: Anal Cancer; Human Papilloma Virus Infection; HIV Infection

Treatments: Procedure: quality-of-life assessment; Other: laboratory biomarker analysis; Procedure: comparison of screening methods; Other: questionnaire administration

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01946139

U01CA121947 (U.S. NIH Grant/Contract)

R01CA163103 (U.S. NIH Grant/Contract)

AMC-084 (Other Identifier)

NCI-2013-01637 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

EXPLORATORY 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.

Enrollment: 276 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

276 participants in 1 patient group

Screening (HSIL detection)

Experimental group

Description:

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 6, 12, 18, and 24 months.

Treatment:

Other: questionnaire administration

Other: laboratory biomarker analysis

Procedure: quality-of-life assessment

Procedure: comparison of screening methods