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Completed

NCT Number: NCT02287961

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Biopsy(ies) during High Resolution Anoscopy

Procedure

only if lesion suggestive of AIN detected during High Resolution Anoscopy

High Resolution Anoscopy biannually

Procedure

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

Primary outcomes

  1. Evaluation of high-grade anal lesions by high resolution anoscopy

    Time frame: Initial inclusion visit

  2. Evaluation of anal HPV infection by DNA, RNA and protein detection

    Time frame: Initial inclusion visit

  3. Quantification of spontaneous regression of high-grade anal lesions

    Time frame: Month 24

Secondary outcomes

  1. Evaluation of anal HPV infection by DNA, RNA and protein detection

    Time frame: Month 6

  2. Evaluation of anal HPV infection by DNA, RNA and protein detection

    Time frame: Month 12

  3. Evaluation of anal HPV infection by DNA, RNA and protein detection

    Time frame: Month 18

  4. Evaluation of anal HPV infection by DNA, RNA and protein detection

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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.

Acronym: APACHES

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Nov 11, 2014
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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