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

Not Applicable

Completed

• Conditions: Hiv Infection
• Interventions: Procedure: Standard proctologic examination; Procedure: High resolution anoscopy; Procedure: Biopsy(ies) during High Resolution Anoscopy; Procedure: High Resolution Anoscopy biannually

• Registration Number: NCT02287961
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Study Start: 2014-12-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 516

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	High resolution anoscopy	* Standard proctologic examination with digital rectal examination and 2 anal swabs at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 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)
Subjects	Biopsy(ies) during High Resolution Anoscopy	* Standard proctologic examination with digital rectal examination and 2 anal swabs at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 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)
Subjects	High Resolution Anoscopy biannually	* Standard proctologic examination with digital rectal examination and 2 anal swabs at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 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)
Subjects	Standard proctologic examination	* Standard proctologic examination with digital rectal examination and 2 anal swabs at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 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)

Primary Outcome Measures

Name	Time	Method
Evaluation of high-grade anal lesions by high resolution anoscopy	Initial inclusion visit
Quantification of spontaneous regression of high-grade anal lesions	Month 24
Evaluation of anal HPV infection by DNA, RNA and protein detection	Initial inclusion visit

Secondary Outcome Measures

Name	Time	Method
Evaluation of anal HPV infection by DNA, RNA and protein detection	Month 24

Trial Locations

Locations (1)

Diaconesses; 🇫🇷 Paris, France