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

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: Hiv Infection

Treatments: Procedure: High Resolution Anoscopy biannually; Procedure: Biopsy(ies) during High Resolution Anoscopy; Procedure: High resolution anoscopy; Procedure: Standard proctologic examination

Study type: Interventional

Funder types: Other

Identifiers

NCT02287961

ANRS EP57 APACHES

Details and patient eligibility

About

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

Full 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

Enrollment: 516 patients

Sex: Male

Ages: 35 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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516 participants in 1 patient group

Subjects

Other group

Description:

* 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)

Treatment:

Procedure: Standard proctologic examination

Procedure: High resolution anoscopy

Procedure: Biopsy(ies) during High Resolution Anoscopy

Procedure: High Resolution Anoscopy biannually