Hiv InfectionAPACHESNCT02287961
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
A study testing Standard proctologic examination, High resolution anoscopy and Biopsy(ies) during High Resolution Anoscopy in people with Hiv Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years, men only
- Conditions the study is for
- Hiv Infection
- What is being tested?
- Standard proctologic examination, High resolution anoscopy and Biopsy(ies) during High Resolution Anoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2014to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read more
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
Read the 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
- Conditions
- Hiv Infection
- Being tested
- Standard proctologic examination, High resolution anoscopy, Biopsy(ies) during High Resolution Anoscopy, High Resolution Anoscopy biannually
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard proctologic examinationProcedure or surgery
(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 anoscopyProcedure or surgery
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 AnoscopyProcedure or surgery
only if lesion suggestive of AIN detected during High Resolution Anoscopy
High Resolution Anoscopy biannuallyProcedure or surgery
Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Other | * 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) Receives: Procedure: Standard proctologic examination; Procedure: High resolution anoscopy; Procedure: Biopsy(ies) during High Resolution Anoscopy; Procedure: High Resolution Anoscopy biannually |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of high-grade anal lesions by high resolution anoscopy
Measured: Initial inclusion visit
Evaluation of anal HPV infection by DNA, RNA and protein detection
Measured: Initial inclusion visit
Quantification of spontaneous regression of high-grade anal lesions
Measured: Month 24
Secondary outcomes (4)
Evaluation of anal HPV infection by DNA, RNA and protein detection
Measured: Month 6
Evaluation of anal HPV infection by DNA, RNA and protein detection
Measured: Month 12
Evaluation of anal HPV infection by DNA, RNA and protein detection
Measured: Month 18
Evaluation of anal HPV infection by DNA, RNA and protein detection
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study start2 Dec 2014
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hiv InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle Etienney, Principal investigator, Hôpital Diaconesses ParisGary Clifford, Study director, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287961
- Sponsor's protocol ID
- ANRS EP57 APACHES
- Acronym
- APACHES
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2014
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Combes JD, Didelot JM, Radenne S, Zaegel-Faucher O, Lesage AC, Siproudhis L, Piroth L, Marchand L, Heard I, Hoyeau N, Henno S, Darragh TM, Alberts CJ, Clifford GM, Etienney I; ANRS-EP57-APACHES Study group. Cumulative Detection of Anal High-Grade Squamous Intraepithelial Lesions Over 2-Year Follow-up in Men Who Have Sex With Men Living With Human Immunodeficiency Virus in France. J Infect Dis. 2024 Jul 25;230(1):55-60. doi: 10.1093/infdis/jiad506.
PubMed 39052708Alberts CJ, Heard I, Canestri A, Marchand L, Flejou JF, Piroth L, Ferry T, Didelot JM, Siproudhis L, Henno S, Poizot-Martin I, Darragh TM, Clifford GM, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Incidence and Clearance of Anal Human Papillomavirus (HPV)-16 and HPV-18 Infection, and Their Determinants, Among Human Immunodeficiency Virus-Infected Men Who Have Sex With Men in France. J Infect Dis. 2020 Apr 7;221(9):1488-1493. doi: 10.1093/infdis/jiz623.
PubMed 31754686Clifford GM, Siproudhis L, Piroth L, Poizot-Martin I, Radenne S, Reynes J, Lesage A, Heard I, Henno S, Flejou JF, Marchand L, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Determinants of high-grade anal intraepithelial lesions in HIV-positive MSM. AIDS. 2018 Oct 23;32(16):2363-2371. doi: 10.1097/QAD.0000000000001947.
PubMed 30005009Combes JD, Heard I, Poizot-Martin I, Canestri A, Lion A, Piroth L, Didelot JM, Ferry T, Patey O, Marchand L, Flejou JF, Clifford GM, Etienney I; ANRS EP57 APACHES Study group. Prevalence and Risk Factors for Anal Human Papillomavirus Infection in Human Immunodeficiency Virus-Positive Men Who Have Sex with Men. J Infect Dis. 2018 Apr 23;217(10):1535-1543. doi: 10.1093/infdis/jiy059.
PubMed 29394362
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02287961
- Acronym / sponsor ID
- APACHES / ANRS EP57 APACHES
- Conditions
- Hiv Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 2 Dec 2014 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Other | Procedure: Standard proctologic examination, Procedure: High resolution anoscopy, Procedure: Biopsy(ies) during High Resolution Anoscopy, Procedure: High Resolution Anoscopy biannually* 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) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Subjects |
| High resolution anoscopyat initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits | Procedure or surgery | Subjects |
| Biopsy(ies) during High Resolution Anoscopyonly if lesion suggestive of AIN detected during High Resolution Anoscopy | Procedure or surgery | Subjects |
| High Resolution Anoscopy biannuallyOnly if high-grade lesion (ASC-H, HSIL ou AIN2/3) | Procedure or surgery | Subjects |
Primary outcome
Evaluation of high-grade anal lesions by high resolution anoscopy
Time frame: Initial inclusion visit
Evaluation of anal HPV infection by DNA, RNA and protein detection
Time frame: Initial inclusion visit
Quantification of spontaneous regression of high-grade anal lesions
Time frame: Month 24
4 secondary outcomes
Evaluation of anal HPV infection by DNA, RNA and protein detection
Time frame: Month 6
Evaluation of anal HPV infection by DNA, RNA and protein detection
Time frame: Month 12
Evaluation of anal HPV infection by DNA, RNA and protein detection
Time frame: Month 18
Evaluation of anal HPV infection by DNA, RNA and protein detection
Time frame: Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 39052708Combes JD, Didelot JM, Radenne S, Zaegel-Faucher O, Lesage AC, Siproudhis L, Piroth L, Marchand L, Heard I, Hoyeau N, Henno S, Darragh TM, Alberts CJ, Clifford GM, Etienney I; ANRS-EP57-APACHES Study group. Cumulative Detection of Anal High-Grade Squamous Intraepithelial Lesions Over 2-Year Follow-up in Men Who Have Sex With Men Living With Human Immunodeficiency Virus in France. J Infect Dis. 2024 Jul 25;230(1):55-60. doi: 10.1093/infdis/jiad506.
- Results publication: PubMed 31754686Alberts CJ, Heard I, Canestri A, Marchand L, Flejou JF, Piroth L, Ferry T, Didelot JM, Siproudhis L, Henno S, Poizot-Martin I, Darragh TM, Clifford GM, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Incidence and Clearance of Anal Human Papillomavirus (HPV)-16 and HPV-18 Infection, and Their Determinants, Among Human Immunodeficiency Virus-Infected Men Who Have Sex With Men in France. J Infect Dis. 2020 Apr 7;221(9):1488-1493. doi: 10.1093/infdis/jiz623.
- Results publication: PubMed 30005009Clifford GM, Siproudhis L, Piroth L, Poizot-Martin I, Radenne S, Reynes J, Lesage A, Heard I, Henno S, Flejou JF, Marchand L, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Determinants of high-grade anal intraepithelial lesions in HIV-positive MSM. AIDS. 2018 Oct 23;32(16):2363-2371. doi: 10.1097/QAD.0000000000001947.
- Results publication: PubMed 29394362Combes JD, Heard I, Poizot-Martin I, Canestri A, Lion A, Piroth L, Didelot JM, Ferry T, Patey O, Marchand L, Flejou JF, Clifford GM, Etienney I; ANRS EP57 APACHES Study group. Prevalence and Risk Factors for Anal Human Papillomavirus Infection in Human Immunodeficiency Virus-Positive Men Who Have Sex with Men. J Infect Dis. 2018 Apr 23;217(10):1535-1543. doi: 10.1093/infdis/jiy059.
- Agence nationale de recherches sur le sida et les hépatites virales (ANRS)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Etienney principal investigator
Hôpital Diaconesses Paris
Gary Clifford study director
International Agency for Research on Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard proctologic examination, High resolution anoscopy and Biopsy(ies) during High Resolution Anoscopy in people with Hiv Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of high-grade anal lesions by high resolution anoscopy (time frame: Initial inclusion visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02287961, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.