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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02287961

Acronym

APACHES

Enrollment

516

Registered

2014-11-11

Start date

2014-12-02

Completion date

2022-06-30

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv Infection

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

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

Interventions

PROCEDUREStandard 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

PROCEDUREHigh resolution anoscopy

at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits

PROCEDUREBiopsy(ies) during High Resolution Anoscopy

only if lesion suggestive of AIN detected during High Resolution Anoscopy

PROCEDUREHigh Resolution Anoscopy biannually

Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Evaluation of anal HPV infection by DNA, RNA and protein detection	Month 6

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026