Clinical trial NCT01946139: Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Official title: Screening HIV-Infected Women for Anal Cancer Precursors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Cancer
HIV Infection
Human Papilloma Virus Infection
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-19
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
timeFrame: at baseline
measure: Prevalence of HSIL
timeFrame: at baseline
measure: Sensitivity of Each of the Methods of APTIMA Assay at Baseline
timeFrame: at baseline
measure: Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry
timeFrame: Up to 2 years
Secondary outcomes:
measure: Acceptability of Anal Cancer Screening
timeFrame: at baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Clinical AIDS Research and Education (CARE) Center
state: California
city: San Francisco
country: United States
facility: Ucsf Ancre
state: California
city: Chicago
country: United States
facility: John H. Stroger Hospital of Cook County
state: Illinois
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill-Cornell Medical College
state: New York
city: New York
country: United States
facility: Laser Surgery Care Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Comprehensive Cancer Center
Study officials:
affiliation: AIDS Associated Malignancies Clinical Trials Consortium
name: Elizabeth Chiao
role: PRINCIPAL_INVESTIGATOR
References: