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

NCT02287961 | Completed

• 1 other identifier: ANRS EP57 APACHES
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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

Conditions

Hiv Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (1)

Subjects

OTHER

* 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; Procedure: High resolution anoscopy; Procedure: Biopsy(ies) during High Resolution Anoscopy; Procedure: High Resolution Anoscopy biannually

Interventions

Standard proctologic examination PROCEDURE

(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

Subjects

High resolution anoscopy PROCEDURE

at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits

Subjects

Biopsy(ies) during High Resolution Anoscopy PROCEDURE

only if lesion suggestive of AIN detected during High Resolution Anoscopy

Subjects

High Resolution Anoscopy biannually PROCEDURE

Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)

Subjects

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Contraindication to biopsy
• History of anal cancer or pelvic radiotherapy
• AIN2/3 treated during previous year
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Diaconesses

Paris, France

Location

Related Publications (4)

• Combes JD, Didelot JM, Radenne S, Zaegel-Faucher O, Lesage AC, Siproudhis L, Piroth L, Marchand L, Heard I, Hoyeau N, Henno S, Darragh TM, Alberts CJ, Clifford GM, Etienney I; ANRS-EP57-APACHES Study group. Cumulative Detection of Anal High-Grade Squamous Intraepithelial Lesions Over 2-Year Follow-up in Men Who Have Sex With Men Living With Human Immunodeficiency Virus in France. J Infect Dis. 2024 Jul 25;230(1):55-60. doi: 10.1093/infdis/jiad506.

  PMID: 39052708 BACKGROUND

• Alberts CJ, Heard I, Canestri A, Marchand L, Flejou JF, Piroth L, Ferry T, Didelot JM, Siproudhis L, Henno S, Poizot-Martin I, Darragh TM, Clifford GM, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Incidence and Clearance of Anal Human Papillomavirus (HPV)-16 and HPV-18 Infection, and Their Determinants, Among Human Immunodeficiency Virus-Infected Men Who Have Sex With Men in France. J Infect Dis. 2020 Apr 7;221(9):1488-1493. doi: 10.1093/infdis/jiz623.

  PMID: 31754686 RESULT

• Clifford GM, Siproudhis L, Piroth L, Poizot-Martin I, Radenne S, Reynes J, Lesage A, Heard I, Henno S, Flejou JF, Marchand L, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Determinants of high-grade anal intraepithelial lesions in HIV-positive MSM. AIDS. 2018 Oct 23;32(16):2363-2371. doi: 10.1097/QAD.0000000000001947.

  PMID: 30005009 RESULT

• Combes JD, Heard I, Poizot-Martin I, Canestri A, Lion A, Piroth L, Didelot JM, Ferry T, Patey O, Marchand L, Flejou JF, Clifford GM, Etienney I; ANRS EP57 APACHES Study group. Prevalence and Risk Factors for Anal Human Papillomavirus Infection in Human Immunodeficiency Virus-Positive Men Who Have Sex with Men. J Infect Dis. 2018 Apr 23;217(10):1535-1543. doi: 10.1093/infdis/jiy059.

  PMID: 29394362 RESULT

Related Links

• Agence nationale de recherches sur le sida et les hépatites virales (ANRS)

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Isabelle Etienney

  Hôpital Diaconesses Paris

  PRINCIPAL INVESTIGATOR

• Gary Clifford

  International Agency for Research on Cancer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: November 11, 2014
• Study Start: December 2, 2014
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)