NCT02287961

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: Male
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

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 (Atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (ASC-H), High grade Superficial Intra-epithelial Lesion (HSIL) or AIN2/3): \- HRA biannually

Conditions

• Hiv Infection

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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
PROCEDURE	Biopsy(ies) during High Resolution Anoscopy	only if lesion suggestive of AIN detected during High Resolution Anoscopy
PROCEDURE	High Resolution Anoscopy biannually	Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)

Timeline

• Start date: 2014-12-02
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2014-11-11
• Last updated: 2024-08-20

Locations

1 site across 1 country: France