Status:
COMPLETED
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
Hiv Infection
Eligibility:
MALE
35-80 years
Phase:
NA
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 observ...
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 ex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT02287961
Start Date
December 2 2014
End Date
June 30 2022
Last Update
August 20 2024
Active Locations (1)
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1
Diaconesses
Paris, France