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

NCT02287961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2026-04-23

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Isabelle Etienney · Hôpital Diaconesses Paris

  • Gary Clifford · International Agency for Research on Cancer

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-02
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287961 on ClinicalTrials.gov