Anal HPV Infection and Abnormal Cytology in HIV-infected Women

HIV Infections Clinical Trial

Official title:

Anal HPV Infection and Abnormal Cytology in HIV-infected Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933140
• Other study ID #: H-25758
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: November 16, 2015
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: November 2015
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The population of HIV infected women seen at Boston Medical Center may have a higher frequency of anal cytologic and histologic abnormalities than what is reported for the non-HIV infected population.

Description:

BACKROUND FOR THIS STUDY Anal cancer is a growing problem in the US. The incidence of anal cancer has increased among both men (160%) and women (78%) from 1973 to 2000 in the US [1]. In HIV-infected men the incidence of SCCA (squamous cell cancer of the anus) was found to range from 49-92 per 100,000 patient years [2]. This prompted recommendations on screening for anal cancer in this population. HIV-infected women are also at increased risk for developing anal cancer. A study based on data from AIDS and cancer registries found that the risk of anal cancer among women in the general population is about 1.2% and it increases up to 3.9% in the HIV-infected women. In addition, HIV-infected women had eight times the risk of in situ anal cancer compared with the number of expected cases [3].

SCCA appears to have many similarities to cervical cancers. HPV has been detected in 88% of anal cancer specimens with HPV-16 found in 73% of SCCA and HPV-18 in 7% [1]. In addition, SCCA develops in the transformation zone between the squamous epithelium of the anus and the columnar epithelium of the rectum, is frequently associated with dysplasia of the anus and may be preceded by squamous intraepithelial changes which are also associated with HPV.

Cervical cytology, also known as pap smear, can detect cervical cancer and its precursors. Countries who have adopted cervical cancer screening programs have had dramatic decreases in both the morbidity and mortality rates of cervical cancer.

Anal cytology may also be used to screen for HPV associated anal lesions, and among HIV-infected men who have sex with men, an abnormal cytology is frequently associated with a dysplastic squamous cell lesion of the anus. Anal HPV infections (high risk types) have been found in 53 ¿ 95% of HIV-infected men. Abnormal anal cytology has been found in 41-81% of HIV-infected men screened with high-grade cytologic findings in 2-25% of these patients [2].

There have been only a few studies looking at anal cytology in HIV-infected women. The largest study (n=235), by Holly and Palefsky [4], found that HIV positive women had a 26% prevalence of anal cytologic abnormalities (mostly atypical squamous cells of undetermined significance [ASCUS] and low grade squamous intraepithelial lesions [LSIL]). Forty-six of these women with abnormal cytology (60) underwent high resolution anoscopy (HRA) and 14 were found to have biopsy proven HSIL.

Several risk factors for anal cytologic abnormalities in women have been suggested, such as positive anal HPV test, history of anal intercourse, history of cervical squamous intraepithelial lesions (SIL), history of vulvar warts, multifocal cervical SIL, history of sexually transmitted infections, more than 10 sexual partners, history of cervical, vulvar or vaginal cancer, immunosuppression after solid organ transplantation, HIV infection, long-term corticosteroids use and cigarette smoking.

It has been suggested that all HIV-infected women, women with cervical cancer and women with high-grade vulvar disease or cancer should be screened for anal cytologic abnormalities. However, as described above there is very scanty literature describing the prevalence and incidence in this patient population and the largest study was conducted prior to the HAART era.

We plan to estimate the prevalence and 6-12 month incidence of abnormal anal cytology with histologic correlates in the HIV-infected women seen at BMC. We hope that the information will allow us to make screening recommendations for this patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age 18-64 years

• HIV infected women

• due for cervical cytologic screening

Exclusion Criteria:

• Pregnancy

• On chronic anticoagulation medication

• Life expectancy of the woman is less than 1 year

• If the woman has had a cervical or anal pap test in the last 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer Screening
• HIV Infections
• Infection
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective is to determine the rate of anal cytologic and histologic abnormalities in HIV infected women at Boston Medical Center.		2 years	No
Secondary	Identify risk factors for anal cytologic and histologic abnormalities in HIV infected women at BMC		2 years	No