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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Hiv Infection

Intervention / Treatment
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* Procedure: Standard proctologic examination
* Procedure: High resolution anoscopy
* Procedure: Biopsy(ies) during High Resolution Anoscopy
* Procedure: High Resolution Anoscopy biannually


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects<br>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) | Procedure: Standard proctologic examination<br>* (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<br>Procedure: High resolution anoscopy<br>* at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits<br>Procedure: Biopsy(ies) during High Resolution Anoscopy<br>* only if lesion suggestive of AIN detected during High Resolution Anoscopy<br>Procedure: High Resolution Anoscopy biannually<br>* Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of high-grade anal lesions by high resolution anoscopy |  | Initial inclusion visit | 
| Evaluation of anal HPV infection by DNA, RNA and protein detection |  | Initial inclusion visit | 
| Quantification of spontaneous regression of high-grade anal lesions |  | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of anal HPV infection by DNA, RNA and protein detection |  | Month 6 | 
| Evaluation of anal HPV infection by DNA, RNA and protein detection |  | Month 12 | 
| Evaluation of anal HPV infection by DNA, RNA and protein detection |  | Month 18 | 
| Evaluation of anal HPV infection by DNA, RNA and protein detection |  | Month 24 |