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NCT02287961 Clinical Trial

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

Hiv Infection Clinical Trial

— APACHES  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02287961
Other study ID # ANRS EP57 APACHES
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date June 2022

Study information
Verified date December 2020
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date June 2022
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender Male
Age group 35 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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
• 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)

Locations
Country Name City State
France Diaconesses Paris

Sponsors (1)
Lead Sponsor Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of high-grade anal lesions by high resolution anoscopy Initial inclusion visit
Primary Evaluation of anal HPV infection by DNA, RNA and protein detection Initial inclusion visit
Primary Quantification of spontaneous regression of high-grade anal lesions Month 24
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 6
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 12
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 18
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 24
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