Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments standard proctologic examination, high resolution anoscopy, biopsy(ies) during high resolution anoscopy, high resolution anoscopy biannually
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date December 2014
End date December 2016
Trial size 500 participants
Trial identifier NCT02287961, ANRS EP57 APACHES

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(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)
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
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)

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male participants from 35 years up to 80 years old.

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

Additional Information

Official 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.
Principal investigator Isabelle Etienney
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).