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

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02287961

Collaborator

(none)

500

Enrollment

Location

Arm

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hiv Infection	Procedure: Standard proctologic examination Procedure: High resolution anoscopy Procedure: Biopsy(ies) during High Resolution Anoscopy Procedure: High Resolution Anoscopy biannually	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Actual Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diaconesses	Paris		France

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

ANRS, Emerging Infectious Diseases

ClinicalTrials.gov Identifier:

NCT02287961

Other Study ID Numbers:

ANRS EP57 APACHES

First Posted:

Nov 11, 2014

Last Update Posted:

Dec 7, 2020

Last Verified:

Dec 1, 2020

Additional relevant MeSH terms:

Infections

Communicable Diseases

Papillomavirus Infections

Study Results

No Results Posted as of Dec 7, 2020