Loading clinical trials...

Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men | Clinical Trials | Clareo Health

COMPLETEDNA

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.

NCT02287961•ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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

Age

35 - 80 years

Sex

MALE

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

Locations (1)

Diaconesses

Paris, France

Key Dates

Start Date

December 2, 2014

Primary Completion Date

June 30, 2022

Completion Date

June 30, 2022

Last Updated

August 20, 2024

Enrollment

516

ACTUAL participants

Conditions

Hiv Infection

Interventions

Standard proctologic examination

PROCEDURE

High resolution anoscopy

PROCEDURE

Biopsy(ies) during High Resolution Anoscopy

PROCEDURE

High Resolution Anoscopy biannually

PROCEDURE

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Skeletal Muscle Energetics and Fatiguability in Older Individuals

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

Comprehensive HIV and Harm Prevention Via Telehealth