Chronic HIV InfectionHEPAPRISNCT05649202
Hepatitis C in Prison: Study of Screening and Rapid Treatment (HEPAPRIS)
An observational study of Chronic HIV Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Due to the high prevalence of HCV in prison and the risk of transmission between inmates, the management of hepatitis C and its treatment must be optimal following the recommendations of AFEF. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic HIV Infection
- What is being tested?
- Xpert® HCV Viral test and FibroScan® test
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2023to Jul 2025
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Persons detained at the Paris-La Santé Penitentiary Center (CPPLS) from the state of liberty or transferred from another prison who have a positive HCV serology
Who may be able to join
- Adult patient (>/= 18 years old),
- Persons detained at the Paris-La Santé Penitentiary Center (CPPLS) coming from the state of freedom or transferred from another penitentiary establishment
- Serology HCV positive
Who cannot join
- Major psychiatric disorders with loss of discernment
- Persons under guardianship or curatorship
- Persons not affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site
Internal Medicine Service, Cochin Hospital (Consultation and Ambulatory Care Unit (UCSA) within the Paris-La Santé Penitentiary Center (CPPLS))
Paris, 75014
About this study
Official title: Hepatitis C in Prison: Study of Rapid Diagnosis and Treatment
Due to the high prevalence of HCV in prison and the risk of transmission between inmates, the management of hepatitis C and its treatment must be optimal following the recommendations of AFEF.
The purpose of this study is to assess the treatment starting delay from the date of incarceration of inmates with chronic HCV infection (hepatitis C).
Read the detailed description
Detainees have specific health needs due to the high prevalence of several pathologies (HIV, HCV, tuberculosis, chronic diseases, addictions, psychiatric disorders associated in some cases with suicide attempts, etc.) and a degraded state of health. Detainees are frequently from the most disadvantaged social groups with low use of the health system prior to incarceration (drug users, people in precarious situations, migrants).
Although there is no data available in France about the incidence of HCV on inmates, several studies in France have documented exposure to the risk of transmission of hepatitis C through drug injection practices and sharing of injection equipment. The ANRS-Coquelicot survey focused at the national level on drug users attending the center of reception and support to risk reduction for drug users and the center of Care, Support and Prevention of addiction. In this survey, 12% of drug users reported injecting drugs during one of their incarcerations (61% of these users reported having been incarcerated at least once in their lifetime) and 30% reported sharing their injection equipment on that occasion [5]. These data have been confirmed in local studies that show practices in the reuse and share of injection equipment [6]. The PREVACAR survey showed that 18% of prison staff reported finding syringes in detention in the past 12 months [7]. These data are confirmed by the PRIDE survey in which one-third of caregivers reported having treated abscesses in inmates, probably related to injection practices [8].
Because of this high prevalence and the risk of transmission between inmates, treatment of hepatitis C in prison is highly recommended ([9], [10]).
However, there are difficulties in providing treatment. The main obstacle initially identified in 2014-15 was financial. Health care staff still face other challenges, particularly the difficulty of obtaining escorts in sufficient numbers to access technical trays and various consultations of local hospitals, with which the health units operate, and only 50% of medical extractions are carried out [12].
In addition, the conditions of medical extractions, with the almost systematic use of handcuffs and the frequent presence of supervisors at the consultation, while the assessment of the level of security to be implemented must be individualized (conditions noted by the evaluation report of the action plan and by the Controller of places of deprivation of liberty ( notice of 16/07/2015) often result in refusals on the part of detainees.
Another obstacle to the treatment of inmates is the short length of incarceration in a detention facility with an unknown release date for persons on a warrant of deposit. The most common causes of discontinued treatment is release (8%) (1.4%)) [13]. The rapid start of treatment for 8 or 12 weeks will prevent the interruption of most treatments. In addition, extra-carceral consultations are offered to all inmates leaving the CPPLS. This possibility is recorded in the welcome booklet and will be recalled when the treatment is started. These consultations are made by UCSA's general practitioners every morning from Tuesday to Friday from 8:30 a.m. to 12:30 p.m., without an appointment, at the Achard Pavilion Polyclinic at Cochin Hospital.
In accordance with the recommendations of the French Association for the Liver Study (AFEF) [14] this study proposes to optimize the medical care of prisoners with chronic HCV infection by reducing the time between diagnosis and on the way to AAD treatment, by using of the Xpert test® to determine the presence of viral RNA and also by extractions through a Fibroscan® to assess the degree of liver fibrosis.
This study proposes to determine the DAA (Direct-Acting Antiviral) treatment time frame defined by the time between the day of incarceration and the day of the start of DAA treatment.
- Conditions
- Chronic HIV Infection
- Being tested
- Xpert® HCV Viral test, FibroScan® test
- Keywords
- Hepatitis C, DAA, HCV Viral test, liver fibrosis
- Medical subject headings
- Hepatitis C, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert® HCV Viral testOther
an additional sample of 5 ml of blood will be taken for real-time HCV PCR by Xpert®, in addition to the blood samples taken as part of routine care.
FibroScan® testOther
Also called Presence of liver fibrosis Presence and importance of fat overload in the liver
A non invasive test made on a small area of skin coated with a gel
| Study group | Role | What they receive |
|---|---|---|
| All inmates entering the CPPLS | Patients with positive HCV serology Receives: Other: Xpert® HCV Viral test; Other: FibroScan® test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay to treat inmates with chronic HCV infection.
The time frame for Direct-Acting Antiviral (DAA) treatment is defined by the time between the day of incarceration and the day of the DAA started.
Measured: up to 8 days from incarceration
Secondary outcomes (4)
Describe the epidemiological data of the prison population of the Paris-La Santé Penitentiary Center (CPPLS) with positive HCV serology
Proportion of patients with positive HCV serology and description of clinical characteristics : age, transmission mode, co-infections (HIV, HBV) and comorbidities (alcohol, obesity, diabetes, renal failure), history of anti-HCV treatment.
Measured: At the inclusion
Evaluate the rate of positive viral loads and describe the HCV genotypes in positive patients
Proportion of patients with a positive viral load by Xpert® HCV Viral test and proportion of the different HCV genotypes represented
Measured: At the inclusion
Evaluate liver fibrosis of inmates with a positive HCV viral load
Proportion of patients with liver fibrosis assessed by FibroScan® test (level F1, F2, F3, F4) among patients with positive HCV viral load
Measured: At the inclusion
Evaluate the cure rate at 12 weeks after the end of treatment
- Proportion of patients with a negative HCV viral load at 12 weeks after stopping treatment
- Cures defined as an undetectable viral load 12 weeks after stopping treatment
- Duration of hepatitis C treatment
Measured: 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: No patient eligible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic HIV InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Benjamin ANDREW SILBERMANN, MsD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649202
- Sponsor's protocol ID
- APHP190948
- Other IDs
- 2019-A01418-49
- Acronym
- HEPAPRIS
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiron E, Jauffret-Roustide M, Le Strat Y, Chemlal K, Valentin MA, Serre P, et al. Prévalence de l'infection par le VIH et le virus de l'hépatite C chez les personnes détenues en France. Résultats de l'enquête Prévacar 2010. Bull Epidemiol Hebd 2013 ; 35-36 : 445-50.
Semaille C, Le Strat Y, Chiron E, Chemlal K, Valantin MA, Serre P, Cate L, Barbier C, Jauffret-Roustide M; Prevacar Group. Prevalence of human immunodeficiency virus and hepatitis C virus among French prison inmates in 2010: a challenge for public health policy. Euro Surveill. 2013 Jul 11;18(28):20524. doi: 10.2807/1560-7917.es2013.18.28.20524.
PubMed 23870097Jauffret-Roustide M, Le Strat Y, Couturier E, Thierry D, Rondy M, Quaglia M, Razafandratsima N, Emmanuelli J, Guibert G, Barin F, Desenclos JC. A national cross-sectional study among drug-users in France: epidemiology of HCV and highlight on practical and statistical aspects of the design. BMC Infect Dis. 2009 Jul 16;9:113. doi: 10.1186/1471-2334-9-113.
PubMed 19607712Sannier O, Verfaillie F, Lavielle D. [Risk reduction and drug use in detention: study about the detainees of Liancourt Penitentiary]. Presse Med. 2012 Jul;41(7-8):e375-85. doi: 10.1016/j.lpm.2011.12.015. Epub 2012 Mar 2. French.
PubMed 22386285Chemlal K, Bouscaillou J, Jauffret-Roustide M, Semaille C, Barbier C, Michon C, et al. Offre de soins en milieu carcéral en France : infection par le VIH et les hépatites. Enquête Prévacar, 2010. Bull Epidemiol Hebd 2012 ; 10-11 : 131-34.
Michel L, Lions C, Van Malderen S, Schiltz J, Vanderplasschen W, Holm K, Kolind T, Nava F, Weltzien N, Moser A, Jauffret-Roustide M, Maguet O, Carrieri PM, Brentari C, Stover H. Insufficient access to harm reduction measures in prisons in 5 countries (PRIDE Europe): a shared European public health concern. BMC Public Health. 2015 Oct 27;15:1093. doi: 10.1186/s12889-015-2421-y.
PubMed 26507505Circulaire DGOS/R1/R4/DSS/1A/1C/2A n° 2015-148 du 29 avril 2015 relative à la facturation des AAD pour les patients pris en charge en ambulatoire dans des unités sanitaires en milieu pénitentiaire. http://social-sante.gouv.fr/fichiers/bo/2015/15-06/ste_20150006_0000_0065.pdf
Brahmy B. [Difficulties medical care of persons placed under hand of justice]. Rev Prat. 2013 Jan;63(1):93-6. French.
PubMed 23457838Juan Jd, de la Hoya PS, Marco A, Anton JJ, Faraco I, Yllobre C, Pozo E, Hoyos C. Multicenter study on the discontinuation and efficacy of chronic hepatitis C treatment in the Spanish penitentiary population (EPIBAND study). Eur J Gastroenterol Hepatol. 2014 Oct;26(10):1083-9. doi: 10.1097/MEG.0000000000000163.
PubMed 25076064Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.
PubMed 29534185McHugh MP, Wu AHB, Chevaliez S, Pawlotsky JM, Hallin M, Templeton KE. Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay. J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8.
PubMed 28275079Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, Challies TL, Nasser I, Garg J, Wei LJ, McHutchison JG. Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol. 2015 Apr;13(4):772-9.e1-3. doi: 10.1016/j.cgh.2014.12.014. Epub 2014 Dec 18.
PubMed 25528010
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C in Prison: Study of Rapid Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT05649202
- Acronym / sponsor ID
- HEPAPRIS / APHP190948
- Conditions
- Chronic HIV Infection
- Keywords
- Hepatitis C, DAA, HCV Viral test, liver fibrosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patient eligible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Dec 2022 (actual)
- 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.
Due to the high prevalence of HCV in prison and the risk of transmission between inmates, the management of hepatitis C and its treatment must be optimal following the recommendations of AFEF.
The purpose of this study is to assess the treatment starting delay from the date of incarceration of inmates with chronic HCV infection (hepatitis C).
Detailed description
Detainees have specific health needs due to the high prevalence of several pathologies (HIV, HCV, tuberculosis, chronic diseases, addictions, psychiatric disorders associated in some cases with suicide attempts, etc.) and a degraded state of health. Detainees are frequently from the most disadvantaged social groups with low use of the health system prior to incarceration (drug users, people in precarious situations, migrants).
Although there is no data available in France about the incidence of HCV on inmates, several studies in France have documented exposure to the risk of transmission of hepatitis C through drug injection practices and sharing of injection equipment. The ANRS-Coquelicot survey focused at the national level on drug users attending the center of reception and support to risk reduction for drug users and the center of Care, Support and Prevention of addiction. In this survey, 12% of drug users reported injecting drugs during one of their incarcerations (61% of these users reported having been incarcerated at least once in their lifetime) and 30% reported sharing their injection equipment on that occasion [5]. These data have been confirmed in local studies that show practices in the reuse and share of injection equipment [6]. The PREVACAR survey showed that 18% of prison staff reported finding syringes in detention in the past 12 months [7]. These data are confirmed by the PRIDE survey in which one-third of caregivers reported having treated abscesses in inmates, probably related to injection practices [8].
Because of this high prevalence and the risk of transmission between inmates, treatment of hepatitis C in prison is highly recommended ([9], [10]).
However, there are difficulties in providing treatment. The main obstacle initially identified in 2014-15 was financial. Health care staff still face other challenges, particularly the difficulty of obtaining escorts in sufficient numbers to access technical trays and various consultations of local hospitals, with which the health units operate, and only 50% of medical extractions are carried out [12].
In addition, the conditions of medical extractions, with the almost systematic use of handcuffs and the frequent presence of supervisors at the consultation, while the assessment of the level of security to be implemented must be individualized (conditions noted by the evaluation report of the action plan and by the Controller of places of deprivation of liberty ( notice of 16/07/2015) often result in refusals on the part of detainees.
Another obstacle to the treatment of inmates is the short length of incarceration in a detention facility with an unknown release date for persons on a warrant of deposit. The most common causes of discontinued treatment is release (8%) (1.4%)) [13]. The rapid start of treatment for 8 or 12 weeks will prevent the interruption of most treatments. In addition, extra-carceral consultations are offered to all inmates leaving the CPPLS. This possibility is recorded in the welcome booklet and will be recalled when the treatment is started. These consultations are made by UCSA's general practitioners every morning from Tuesday to Friday from 8:30 a.m. to 12:30 p.m., without an appointment, at the Achard Pavilion Polyclinic at Cochin Hospital.
In accordance with the recommendations of the French Association for the Liver Study (AFEF) [14] this study proposes to optimize the medical care of prisoners with chronic HCV infection by reducing the time between diagnosis and on the way to AAD treatment, by using of the Xpert test® to determine the presence of viral RNA and also by extractions through a Fibroscan® to assess the degree of liver fibrosis.
This study proposes to determine the DAA (Direct-Acting Antiviral) treatment time frame defined by the time between the day of incarceration and the day of the start of DAA treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All inmates entering the CPPLS | – | Other: Xpert® HCV Viral test, Other: FibroScan® testPatients with positive HCV serology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons detained at the Paris-La Santé Penitentiary Center (CPPLS) from the state of liberty or transferred from another prison who have a positive HCV serology
Key inclusion criteria (3 listed)
- Adult patient (>/= 18 years old),
- Persons detained at the Paris-La Santé Penitentiary Center (CPPLS) coming from the state of freedom or transferred from another penitentiary establishment
- Serology HCV positive
Key exclusion criteria (3 listed)
- Major psychiatric disorders with loss of discernment
- Persons under guardianship or curatorship
- Persons not affiliated to a social security scheme
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 |
|---|---|---|
| Xpert® HCV Viral testan additional sample of 5 ml of blood will be taken for real-time HCV PCR by Xpert®, in addition to the blood samples taken as part of routine care. | Other | All inmates entering the CPPLS |
| FibroScan® testAlso: Presence of liver fibrosis Presence and importance of fat overload in the liverA non invasive test made on a small area of skin coated with a gel | Other | All inmates entering the CPPLS |
Primary outcome
Delay to treat inmates with chronic HCV infection.
Time frame: up to 8 days from incarceration
The time frame for Direct-Acting Antiviral (DAA) treatment is defined by the time between the day of incarceration and the day of the DAA started.
4 secondary outcomes
Describe the epidemiological data of the prison population of the Paris-La Santé Penitentiary Center (CPPLS) with positive HCV serology
Time frame: At the inclusion
Evaluate the rate of positive viral loads and describe the HCV genotypes in positive patients
Time frame: At the inclusion
Evaluate liver fibrosis of inmates with a positive HCV viral load
Time frame: At the inclusion
Evaluate the cure rate at 12 weeks after the end of treatment
Time frame: 12 weeks after the end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- BackgroundChiron E, Jauffret-Roustide M, Le Strat Y, Chemlal K, Valentin MA, Serre P, et al. Prévalence de l'infection par le VIH et le virus de l'hépatite C chez les personnes détenues en France. Résultats de l'enquête Prévacar 2010. Bull Epidemiol Hebd 2013 ; 35-36 : 445-50.
- Background: PubMed 23870097Semaille C, Le Strat Y, Chiron E, Chemlal K, Valantin MA, Serre P, Cate L, Barbier C, Jauffret-Roustide M; Prevacar Group. Prevalence of human immunodeficiency virus and hepatitis C virus among French prison inmates in 2010: a challenge for public health policy. Euro Surveill. 2013 Jul 11;18(28):20524. doi: 10.2807/1560-7917.es2013.18.28.20524.
- Background: PubMed 19607712Jauffret-Roustide M, Le Strat Y, Couturier E, Thierry D, Rondy M, Quaglia M, Razafandratsima N, Emmanuelli J, Guibert G, Barin F, Desenclos JC. A national cross-sectional study among drug-users in France: epidemiology of HCV and highlight on practical and statistical aspects of the design. BMC Infect Dis. 2009 Jul 16;9:113. doi: 10.1186/1471-2334-9-113.
- Background: PubMed 22386285Sannier O, Verfaillie F, Lavielle D. [Risk reduction and drug use in detention: study about the detainees of Liancourt Penitentiary]. Presse Med. 2012 Jul;41(7-8):e375-85. doi: 10.1016/j.lpm.2011.12.015. Epub 2012 Mar 2. French.
- BackgroundChemlal K, Bouscaillou J, Jauffret-Roustide M, Semaille C, Barbier C, Michon C, et al. Offre de soins en milieu carcéral en France : infection par le VIH et les hépatites. Enquête Prévacar, 2010. Bull Epidemiol Hebd 2012 ; 10-11 : 131-34.
- Background: PubMed 26507505Michel L, Lions C, Van Malderen S, Schiltz J, Vanderplasschen W, Holm K, Kolind T, Nava F, Weltzien N, Moser A, Jauffret-Roustide M, Maguet O, Carrieri PM, Brentari C, Stover H. Insufficient access to harm reduction measures in prisons in 5 countries (PRIDE Europe): a shared European public health concern. BMC Public Health. 2015 Oct 27;15:1093. doi: 10.1186/s12889-015-2421-y.
- BackgroundCirculaire DGOS/R1/R4/DSS/1A/1C/2A n° 2015-148 du 29 avril 2015 relative à la facturation des AAD pour les patients pris en charge en ambulatoire dans des unités sanitaires en milieu pénitentiaire. http://social-sante.gouv.fr/fichiers/bo/2015/15-06/ste_20150006_0000_0065.pdf
- Background: PubMed 23457838Brahmy B. [Difficulties medical care of persons placed under hand of justice]. Rev Prat. 2013 Jan;63(1):93-6. French.
- Background: PubMed 25076064Juan Jd, de la Hoya PS, Marco A, Anton JJ, Faraco I, Yllobre C, Pozo E, Hoyos C. Multicenter study on the discontinuation and efficacy of chronic hepatitis C treatment in the Spanish penitentiary population (EPIBAND study). Eur J Gastroenterol Hepatol. 2014 Oct;26(10):1083-9. doi: 10.1097/MEG.0000000000000163.
- Background: PubMed 29534185Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.
- Background: PubMed 28275079McHugh MP, Wu AHB, Chevaliez S, Pawlotsky JM, Hallin M, Templeton KE. Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay. J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8.
- Background: PubMed 25528010Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, Challies TL, Nasser I, Garg J, Wei LJ, McHutchison JG. Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol. 2015 Apr;13(4):772-9.e1-3. doi: 10.1016/j.cgh.2014.12.014. Epub 2014 Dec 18.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Benjamin ANDREW SILBERMANN, MsD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic HIV Infection, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Delay to treat inmates with chronic HCV infection. (time frame: up to 8 days from incarceration). 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 NCT05649202, which also lists 12 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 6 May 2026.