Clinical trial NCT02287961: Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv Infection
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2014-11-11
Enrollment: 516
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of high-grade anal lesions by high resolution anoscopy
timeFrame: Initial inclusion visit
measure: Evaluation of anal HPV infection by DNA, RNA and protein detection
timeFrame: Initial inclusion visit
measure: Quantification of spontaneous regression of high-grade anal lesions
timeFrame: Month 24
Secondary outcomes:
measure: Evaluation of anal HPV infection by DNA, RNA and protein detection
timeFrame: Month 6
measure: Evaluation of anal HPV infection by DNA, RNA and protein detection
timeFrame: Month 12
measure: Evaluation of anal HPV infection by DNA, RNA and protein detection
timeFrame: Month 18
measure: Evaluation of anal HPV infection by DNA, RNA and protein detection
timeFrame: Month 24
Other outcomes:
Locations:
city: Paris
country: France
facility: Diaconesses
Study officials:
affiliation: Hôpital Diaconesses Paris
name: Isabelle Etienney
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Gary Clifford
role: STUDY_DIRECTOR
References: