Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-18 @ 2:55 PM
Study NCT ID:
NCT02287961
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2014-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2014-10-15', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hiv Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://anrs.fr', 'label': 'Agence nationale de recherches sur le sida et les hépatites virales (ANRS)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nEstimated enrolment: 500\n\nPrincipal Outcomes\n\n* Detection of high-grade cytological and histological anal lesions by high resolution anoscopy\n* Spontaneous regression of high-grade anal lesions\n* Detection of anal HPV infection\n\nIntervention (procedure):\n\n* Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)\n* 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)\n* High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)\n\nOnly if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):\n\n\\- anal biopsy(ies) during HRA\n\nOnly if high-grade lesion:\n\n\\- HRA biannually', 'detailedDescription': 'Intervention (procedure):\n\n* Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)\n* 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)\n* High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)\n\nOnly if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):\n\n\\- anal biopsy(ies) during HRA\n\nOnly 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):\n\n\\- HRA biannually'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who have sex with men\n* At least 35 years old\n* HIV-positive (documented search of HIV infection, with HIV status determined according to HAS algorithm)\n* Signed informed consent\n* Affiliated to or beneficiary of French social security\n* All severity criteria and evolution of HIV disease are accepted (including AIDS stage and co-infections)\n\nExclusion Criteria:\n\n* Contraindication to biopsy\n* History of anal cancer or pelvic radiotherapy\n* AIN2/3 treated during previous year\n* Current anticancer chemotherapy or within 24 months before inclusion\n* Difficulty in evaluation (anus reshaped and/or scarred)\n* Individual placed under judicial protection\n* Foreseen absence which may hamper participation; insufficient motivation; associated pathology with priority for care'}, 'identificationModule': {'nctId': 'NCT02287961', 'acronym': 'APACHES', 'briefTitle': 'Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'ANRS EP57 APACHES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subjects', 'description': '* 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\n* 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\n* Biopsy(ies) during High Resolution Anoscopy only if lesion suggestive of AIN detected during High Resolution Anoscopy\n* High Resolution Anoscopy biannually only if high-grade lesion (ASC-H, HSIL ou AIN2/3)', 'interventionNames': ['Procedure: Standard proctologic examination', 'Procedure: High resolution anoscopy', 'Procedure: Biopsy(ies) during High Resolution Anoscopy', 'Procedure: High Resolution Anoscopy biannually']}], 'interventions': [{'name': 'Standard proctologic examination', 'type': 'PROCEDURE', 'description': '(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', 'armGroupLabels': ['Subjects']}, {'name': 'High resolution anoscopy', 'type': 'PROCEDURE', 'description': 'at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits', 'armGroupLabels': ['Subjects']}, {'name': 'Biopsy(ies) during High Resolution Anoscopy', 'type': 'PROCEDURE', 'description': 'only if lesion suggestive of AIN detected during High Resolution Anoscopy', 'armGroupLabels': ['Subjects']}, {'name': 'High Resolution Anoscopy biannually', 'type': 'PROCEDURE', 'description': 'Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)', 'armGroupLabels': ['Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Diaconesses', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Isabelle Etienney', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Diaconesses Paris'}, {'name': 'Gary Clifford', 'role': 'STUDY_DIRECTOR', 'affiliation': 'International Agency for Research on Cancer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}