CompletedNot Applicable

Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men

France516 participantsStarted 2014-12-02

Plain-language summary

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

Who can participate

Age range35 Years – 80 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Evaluation of high-grade anal lesions by high resolution anoscopy

Timeframe: Initial inclusion visit

Evaluation of anal HPV infection by DNA, RNA and protein detection

Timeframe: Initial inclusion visit

Quantification of spontaneous regression of high-grade anal lesions

Timeframe: Month 24

Trial details

NCT IDNCT02287961

SponsorANRS, Emerging Infectious Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-30

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