Clinical Trials Logo
  1. Home
  2. HIV Infection
  3. NCT02287961
  4. Details
NCT02287961 Clinical Trial

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

Hiv Infection Clinical Trial

— APACHES  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02287961
Other study ID # ANRS EP57 APACHES
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date June 2022

Study information
Verified date December 2020
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date June 2022
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender Male
Age group 35 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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)

Locations
Country Name City State
France Diaconesses Paris

Sponsors (1)
Lead Sponsor Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of high-grade anal lesions by high resolution anoscopy Initial inclusion visit
Primary Evaluation of anal HPV infection by DNA, RNA and protein detection Initial inclusion visit
Primary Quantification of spontaneous regression of high-grade anal lesions Month 24
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 6
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 12
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 18
Secondary Evaluation of anal HPV infection by DNA, RNA and protein detection Month 24
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02663856 - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed NCT02846402 - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda N/A
Completed NCT02921516 - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings N/A
Completed NCT02663869 - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed NCT02659306 - Metformin Immunotherapy in HIV Infection Phase 1
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Completed NCT02564341 - Targeting Effective Analgesia in Clinics for HIV - Intervention N/A
Active, not recruiting NCT02302950 - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas N/A
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT01830595 - Lactoferrin Treatment in HIV Patients Phase 2
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Completed NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Completed NCT02269605 - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment Phase 1
Completed NCT02525146 - Birmingham Access to Care Study N/A
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT02527135 - Text Messaging to Improve HIV Testing Among Young Women in Kenya N/A
Completed NCT02118168 - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 N/A
Active, not recruiting NCT02602418 - Neural Correlates of Working Memory Training for HIV Patients N/A
Completed NCT01680094 - Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART Phase 1/Phase 2

External Links