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Sponsor: ANRS, Emerging Infectious Diseases
Conditions: Hiv Infection
Interventions: Standard proctologic examination, High resolution anoscopy, Biopsy(ies) during High Resolution Anoscopy, High Resolution Anoscopy biannually
Countries: France
Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution. Estimated enrolment: 500 Principal Outcomes * Detection of high-grade cytological and histological anal lesions by high resolution anoscopy * Spontaneous regression of high-grade anal lesions * Detection of anal HPV infection Intervention (procedure): * Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits) * Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits) * High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits) Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA): \- anal biopsy(ies) during HRA Only if high-grade lesion: \- HRA biannually
Sex: MALE
Age: 35 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Men who have sex with men * At least 35 years old * HIV-positive (documented search of HIV infection, with HIV status determined according to HAS algorithm) * Signed informed consent * Affiliated to or beneficiary of French social security * All severity criteria and evolution of HIV disease are accepted (including AIDS stage and co-infections) Exclusion Criteria: * Contraindication to biopsy * History of anal cancer or pelvic radiotherapy * AIN2/3 treated during previous year * Current anticancer chemotherapy or within 24 months before inclusion * Difficulty in evaluation (anus reshaped and/or scarred) * Individual placed under judicial protection * Foreseen absence which may hamper participation; insufficient motivation; associated pathology with priority for care
- Paris, France