Trial Information

Evaluation of Viral Load Determination and Other Biomarkers of High Risk HPV-Types as a Marker for Progression of Perianal HPV-infections in HIV-positive Men Who Have Sex With Men

Compared to the general population the incidence of anal intraepithelial neoplasia (AIN) and
anal carcinoma (AC) amongst men who have sex with men (MSM) is extremely high (above
70/100,000). While many opportunistic infections have declined since the introduction of
highly active antiretroviral therapy (HAART), the incidence of AC has not fallen. In
contrast, the HAART-related improvement of survival seems to result in an increased risk of
AC in HIV-infected MSM. Screening for cervical intraepithelial neoplasia (CIN) with cervical
cytology and early treatment has resulted in a significant decline in the incidence of
cervical carcinoma. Like cervical cancer, AC may be preventable through identification and
treatment of its precursors. Nevertheless, there has never been an effort to implement an
anal cytology screening program for HIV-infected MSM. Persistent cervical infection with
high-risk HPV-types is indicative for the development of CIN and cervical cancer. As the
prevalence of genital HPV-infections in HIV-infected women and men is very high (up to >
90%), the predictive value of qualitative HPV-DNA detection is limited for cervical cancer
or AC prevention. However, several studies have shown that the number of HPV-DNA copies in
cervical scrapes may be predictive of the severity of underlying cervical dysplasia. Thus,
this prospective study mainly focuses on the predictive value of HPV-DNA load for the
development and clinical progression of AIN in HIV-infected MSM. Besides,
HPV-E6/E7-oncogen-expression using RT-PCR will be determined. Moreover, the course of HPV
viral load under therapy for anal intraepithelial neoplasia, e.g. topical treatment with
imiquimod, will be evaluated. Additionally, immunohistochemical determination of several
proliferative biomarkers as well as cytokines will be performed.