Thus, the study of HPV genotypes coexisting in the anal canal is of high relevance in HIV-infected men, in order to establish further preventive protocols in this specific population

at risk. The aim of this work was to assess the prevalence BAY 80-6946 clinical trial of anal condylomata and their association with HPV genotype-specific infection and cytological abnormalities in the anal canal in HIV-infected men (MSM and heterosexuals). A cross-sectional analysis based on the first (baseline) visit of patients in the Can Ruti HIV-positive Men (CARH·MEN) cohort was performed (University Hospital Germans Trias i Pujol, Badalona, Spain). This cohort was a prospective, single-centre of out-patient HIV-positive men who were annually assessed for HPV infection in the anus, penis and mouth. The protocol, amendments and other materials were approved by the hospital’s independent ethics committee. Consecutive patient recruitment among out-patients who attended their clinical routine control was carried out by one Smoothened Agonist staff care provider from 2005 to 2007 and since 2008 has been carried out by two staff care providers. The patients were informed about the study and invited to visit the Clinical Proctology HIV Unit which was created ad hoc (two afternoons per week). If they agreed to participate,

written informed consent was obtained. HIV-positive men ≥ 18 years old, without a history of (or current) anal cancer, were included in the study. The following data were collected: date of birth, date of HIV-positive diagnosis (time of HIV infection in years), baseline CD4 cell count (the closest value obtained during the participants’ usual clinical

follow-up visits in the HIV Unit before the cytological sample collection), CD4 count nadir (the lowest CD4 value for each patient abstracted from medical records), HIV viral load (the closest value obtained before the sample aminophylline collection), highly active antiretroviral therapy (HAART) previous to inclusion (yes/no) and time on HAART, history of sexually transmitted infections (STIs), alcohol and smoking history, sexual behaviour and number of sexual partners. Baseline CD4 count and CD4 count nadir were determined by flow cytometry, and HIV viral load by Nuclisens (detection limit 80 HIV-1 RNA copies/mL; bioMerieux, Inc., Durham, NC). A clinical examination (visual inspection) and a digital rectal examination were performed at the baseline visit of patients in the CARH·MEN cohort. Samples from the anal canal were collected for detection of HPV infection [multiplex polymerase chain reaction (PCR)]. The anal canal sample was also used to carry out the cytology analysis (Pap test). If the anal cytology result showed a pathological finding, the patient was contacted and informed, and a high-resolution anoscopy (with topical application of 2 minutes of duration with 3% acetic acid to the anal canal) was scheduled.