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Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
Sponsor: ANRS, Emerging Infectious Diseases
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
Official title: Natural History of Anal Human Papillomavirus Infection and Associated Disease in HIV-infected Men Who Have Sex With Men: Towards an Evidence Base for the Prevention of Anal Cancer.
Key Details
Gender
MALE
Age Range
35 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
516
Start Date
2014-12-02
Completion Date
2022-06-30
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Standard proctologic examination
(with digital rectal examination and 2 anal swabs) at initial inclusion visit, M12 and M24 follow-up visits and if applicable M6 and M18 control visits
High resolution anoscopy
at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits
Biopsy(ies) during High Resolution Anoscopy
only if lesion suggestive of AIN detected during High Resolution Anoscopy
High Resolution Anoscopy biannually
Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)
Locations (1)
Diaconesses
Paris, France