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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

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

Interventions

  • 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)

Arms, Groups and Cohorts

  • Other: Subjects
    • 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)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Evaluation of anal HPV infection by DNA, RNA and protein detection
    • Time Frame: Month 6
  • Evaluation of anal HPV infection by DNA, RNA and protein detection
    • Time Frame: Month 12
  • Evaluation of anal HPV infection by DNA, RNA and protein detection
    • Time Frame: Month 18
  • Evaluation of anal HPV infection by DNA, RNA and protein detection
    • Time Frame: Month 24

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 35 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Isabelle Etienney, Principal Investigator, Hôpital Diaconesses Paris
    • Gary Clifford, Study Director, International Agency for Research on Cancer

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