Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
NCT ID: NCT02287961
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
516 participants
INTERVENTIONAL
2014-12-02
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM
NCT03357991
Anal HSIL Screening Algorithm
NCT05531799
IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in HIV Patients
NCT04735445
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
NCT04055142
Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
NCT02059499
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subjects
* Standard proctologic examination with digital rectal examination and 2 anal swabs at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 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)
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
35 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle Etienney
Role: PRINCIPAL_INVESTIGATOR
Hôpital Diaconesses Paris
Gary Clifford
Role: STUDY_DIRECTOR
International Agency for Research on Cancer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diaconesses
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Agence nationale de recherches sur le sida et les hépatites virales (ANRS)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANRS EP57 APACHES
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.