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

April 21, 2026 updated by: ANRS, Emerging Infectious Diseases

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

516

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Diaconesses

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Isabelle Etienney, Hôpital Diaconesses Paris
  • Study Director: Gary Clifford, International Agency for Research on Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2014

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimated)

November 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS EP57 APACHES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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