HIVCO13HepavihNCT03324633
Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With HIV and HCV
An observational study of HIV and Hepatitis C, run by ANRS, Emerging Infectious Diseases.
Trial summary
The ANRS CO13 HEPAVIH cohort is a prospective and multicentric cohort created in 2005 with the originality to cover two therapeutic domains of key importance, AIDS and hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C
- How many people
- 1,850 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Co-infected patients with HIV and HVC who are usually treated in one of the clinical centres of the ANRS CO13 Hepavih network (28 located in metropolitan France since 2014)
Who may be able to join
- All phases of inclusion:
- Patients aged ≥18 years,
- Cover by a social security,
- Able to understand the consent conform.
- Phase 1:
- HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment)
Show all 10Show fewer
- Phase 2:
- HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with protease inhibitor based treatment (PegIFN, Ribavirin and Telaprevir or Boceprevir) or having cleared HCV spontaneously in the absence of anti-HCV treatment
- Phase 3:
- HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with DAA anti-HCV treatment (all combinations)
Who cannot join
- Patients <18 years old
- So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
- Without an healthcare insurance
About this study
Official title: Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With Hepatitis C and Human Immunodeficiency Virus (Collaboration Inter Cohortes et Centres Cliniques de Sujets Co-infectés Par Les Virus de l'immunodéficence Humaine et de l'hépatite C)
The ANRS CO13 HEPAVIH cohort is a prospective and multicentric cohort created in 2005 with the originality to cover two therapeutic domains of key importance, AIDS and hepatitis C. The cohort, is unique in Europe with more than 1800 participants followed over 10 years including quality of life and compliance to treatment data.
Read the detailed description
The cohort has been created in 2005 with the general objective to better define the natural history of HCV/HIV co-infection in terms of morbidity and mortality. Furthermore, the cohort aims to determine factors associated with morbidity and mortality and to better understand interactions between the two viruses and their respective treatments.
The ANRS CO13 Hepavih is currently composed of 28 french metropolitan clinical centers of infectious diseases and hepatogy diseases (mostly teaching hospital).
The period of patient inclusion has been divided in three distinct phases: the first phase (Phase 1) that started in 2005 and ended in 2008, was dedicated to the inclusion of adult HCV/HIV co-infected patients. The following inclusion phase (Phase 2) that concerns patients who received a triple-agent anti-HCV therapy including Boceprevir or Telaprevir, started in 2008 and ended in march 2016. The third one (Phase 3) focusing on patients initiating a DAA anti HCV treatment started in June 2014 and ended in November 2015. Regarding Phase 3, the specific objectives were organized into five thematic domains including clinic, virology, pharmacology, public health and methodology.
Since 31 march 2016, the inclusions are closed and 1,850 patients have been included. The ended of the follow-up is planned on the 31 december 2018.
At the inclusion and during the follow-up period (at least once a year or every 6 months in case of cirrhosis, until 2018 and probably also beyond that date), each HCV/HIV co-infected patient is offered a clinical examination as well as an interview. Additional self-questionnaires are filled by the included patients at the same time points (Social sciences data). The types of data collected from each co-infected patient included in the cohort are organized according to five major thematic classes: socio-demography and behavior, HIV characteristics, HCV characteristics, clinical relevant events, anthropometry, paraclinic data.
The ANRS CO13 HEPAVIH cohort has the purpose to become a facility for specific research regarding the physiopathological and therapeutic aspects of the HCV/HIV co-infection at the disposal of the entire scientific community.
In july 2016, the cohort has pusblished 29 originals articles and 10 as a part of national and European collaborations.
The ANRS CO13 HEPAVIH cohort has adopted functional governance. The Steering Committee, made-up of clinicians, methodologist, the sponsor as well as the cohort coordinators, is focused on logistic and operational aspects of the cohort. The Scientific Committee is the scientific decision-making organization, made-up with scientist experts in main research fields including methodology, hepathology, infectiology, pharmacology, virology and social science, and representatives of the ANRS and patient organizations. It assesses requests for the access to the cohort and provides advices on scientific, methodological and ethical aspects in order to ensure an effective scientific conduct of the research. The Steering Comitee meet once a month and the Scientific Comitee 2/3 times a year.
- Conditions
- HIV, Hepatitis C
- Keywords
- HIV, HCV, cohort, natural history, cure
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve effectiveness and quality of medical care in Hepatitis C in HIV patients
The CRFs compile clinical, biological, genetic and virological data : Clinical events, treatments (HIV, HVC, others), clinical exams (height, weight, hip and waist circumferences), virological : CD4, CD8, HIV RNA, HVC RNA (+genotype), HVB serology, liver functions tests and biology (fibroscan, fibrotest, ultrasound, transaminases, bilirubin, alkaline phosphatase, gamma GT,...), metabolic biochemistry (glycemia, insulin, cholesterol, creatinin, lipase). Patients also completed sociales sciences questionnaires (quality of life, depression,...) During the annual visit, samples are taken : blood for DNA, serum and plasma and are stocked in a biobank used for scientific projects.
Measured: Through study completion : One visit/year for each participant + one additionnal visit every 6 months for patients with a cirhhosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startJun 2005
- Primary completionSep 2017
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Bristol-Myers Squibb, GlaxoSmithKline, Merck Serono International SA, Roche Pharma AG, Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Dominique Salmon, MDPhD, Principal investigator, Assistance Publique des Hôpitaux de Paris -Université Paris DescartesLinda Wittkop, MDPhD, Principal investigator, Inserm U1219 CHU de Bordeaux-Université de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324633
- Sponsor's protocol ID
- ANRS CO13 Hepavih cohort
- Acronym
- CO13Hepavih
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2017
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data have been already shared in context of national, european and international collaborations : ANRS CO12 CIRVIR, ANRS HC EP25 PRETHEVIC, DHOS FIBROSTIC COHERE, … and also with industrial partners.
Publications
Sogni P, Gilbert C, Lacombe K, Piroth L, Rosenthal E, Miailhes P, Gervais A, Esterle L, Chas J, Poizot-Martin I, Dominguez S, Simon A, Morlat P, Neau D, Zucman D, Bouchaud O, Lascoux-Combe C, Bani-Sadr F, Alric L, Goujard C, Vittecoq D, Billaud E, Aumaitre H, Boue F, Valantin MA, Dabis F, Salmon D, Wittkop L. All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus-coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13-HEPAVIH Cohort. Clin Infect Dis. 2016 Sep 15;63(6):763-770. doi: 10.1093/cid/ciw379. Epub 2016 Jun 17.
PubMed 27317796Marcellin F, Protopopescu C, Poizot-Martin I, Miailhes P, Esterle L, Wittkop L, Spire B, Bocquier A, Salmon-Ceron D, Dabis F, Carrieri MP; HEPAVIH ANRS CO13 Study Group. Short article: Fatigue in the long term after HCV treatment in HIV-HCV-coinfected patients: functional limitations persist despite viral clearance in patients exposed to peg-interferon/ribavirin-containing regimens (ANRS CO13-HEPAVIH cohort). Eur J Gastroenterol Hepatol. 2016 Sep;28(9):1003-7. doi: 10.1097/MEG.0000000000000664.
PubMed 27177169Marcellin F, Lions C, Rosenthal E, Roux P, Sogni P, Wittkop L, Protopopescu C, Spire B, Salmon-Ceron D, Dabis F, Carrieri MP; HEPAVIH ANRS CO13 Study Group*. No significant effect of cannabis use on the count and percentage of circulating CD4 T-cells in HIV-HCV co-infected patients (ANRS CO13-HEPAVIH French cohort). Drug Alcohol Rev. 2017 Mar;36(2):227-238. doi: 10.1111/dar.12398. Epub 2016 Apr 13.
PubMed 27073179Carrieri MP, Serfaty L, Vilotitch A, Winnock M, Poizot-Martin I, Loko MA, Lions C, Lascoux-Combe C, Roux P, Salmon-Ceron D, Spire B, Dabis F; ANRS CO13 HEPAVIH Study Group. Cannabis Use and Reduced Risk of Insulin Resistance in HIV-HCV Infected Patients: A Longitudinal Analysis (ANRS CO13 HEPAVIH). Clin Infect Dis. 2015 Jul 1;61(1):40-8. doi: 10.1093/cid/civ217. Epub 2015 Mar 16.
PubMed 25778750Marcellin F, Roux P, Loko MA, Lions C, Caumont-Prim A, Dabis F, Salmon-Ceron D, Spire B, Carrieri MP; HEPAVIH (ANRS CO13) Study Group. High levels of alcohol consumption increase the risk of advanced hepatic fibrosis in HIV/hepatitis C virus-coinfected patients: a sex-based analysis using transient elastography at enrollment in the HEPAVIH ANRS CO13 cohort. Clin Infect Dis. 2014 Oct 15;59(8):1190-2. doi: 10.1093/cid/ciu525. Epub 2014 Jul 11. No abstract available.
PubMed 25015913Salmon D, Bani-Sadr F, Gilbert C, Rosenthal E, Valantin MA, Simon A, Neau D, Morlat P, Loko MA, Wittkop L, Dabis F; ANRS CO13HEPAVIH study group. HCV viral load at baseline and at week 4 of telaprevir/boceprevir based triple therapies are associated with virological outcome in HIV/hepatitis C co-infected patients. J Clin Virol. 2015 Dec;73:32-35. doi: 10.1016/j.jcv.2015.10.010. Epub 2015 Oct 19.
PubMed 26528903ANRS CO13 HEPAVIH Cohort. Regression of liver stiffness after sustained hepatitis C virus (HCV) virological responses among HIV/HCV-coinfected patients. AIDS. 2015 Sep 10;29(14):1821-30. doi: 10.1097/QAD.0000000000000787.
PubMed 26372388Roux P, Lions C, Cohen J, Winnock M, Salmon-Ceron D, Bani-Sadr F, Sogni P, Spire B, Dabis F, Carrieri MP; ANRS-CO13-HEPAVIH Study Group. Impact of HCV treatment and depressive symptoms on adherence to HAART among HIV-HCV-coinfected patients: results from the ANRS-CO13-HEPAVIH cohort. Antivir Ther. 2014;19(2):171-8. doi: 10.3851/IMP2699. Epub 2013 Oct 28.
PubMed 24166726Marcellin F, Roux P, Winnock M, Lions C, Dabis F, Salmon-Ceron D, Loko MA, Spire B, Carrieri MP. Using patient-reported outcomes to improve the management of co-infection with HIV and HCV: the ANRS CO13 HEPAVIH cohort. Expert Rev Gastroenterol Hepatol. 2014 May;8(4):351-8. doi: 10.1586/17474124.2014.888949. Epub 2014 Mar 3.
PubMed 24580042Carrieri MP, Lions C, Sogni P, Winnock M, Roux P, Mora M, Bonnard P, Salmon D, Dabis F, Spire B; ANRS CO13 HEPAVIH Study Group. Association between elevated coffee consumption and daily chocolate intake with normal liver enzymes in HIV-HCV infected individuals: results from the ANRS CO13 HEPAVIH cohort study. J Hepatol. 2014 Jan;60(1):46-53. doi: 10.1016/j.jhep.2013.08.014. Epub 2013 Aug 24.
PubMed 23978720Bani-Sadr F, Loko MA, Pambrun E, Winnock M, Carrieri P, Gilbert C, Duvivier C, Bouchaud O, Gervais A, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Correlates of HIV sustained viral suppression in HIV/hepatitis C virus coinfected patients: possible role of the hepatitis C virus sustained viral response. AIDS. 2014 May 15;28(8):1155-60. doi: 10.1097/QAD.0000000000000218.
PubMed 24499953Winnock M, Bani-Sadr F, Pambrun E, Loko MA, Carrieri P, Neau D, Morlat P, Marchou B, Dabis F, Salmon D; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) CO13 HEPAVIH Study Group. Factors associated with guideline-based hepatitis C virus (HCV) treatment initiation in HIV/HCV-coinfected patients: role of comorbidities and physicians' perceptions. HIV Med. 2013 Aug;14(7):430-6. doi: 10.1111/hiv.12023. Epub 2013 Mar 5.
PubMed 23461846Marcellin F, Lions C, Winnock M, Salmon D, Durant J, Spire B, Mora M, Loko MA, Dabis F, Dominguez S, Roux P, Carrieri MP; ANRS CO13 HEPAVIH Study Group. Self-reported alcohol abuse in HIV-HCV co-infected patients: a better predictor of HIV virological rebound than physician's perceptions (HEPAVIH ARNS CO13 cohort). Addiction. 2013 Jul;108(7):1250-8. doi: 10.1111/add.12149. Epub 2013 Mar 21.
PubMed 23421419Trimoulet P, Merchadou L, Winnock M, Loko MA, Fleury H, Salmon D, Dabis F, Neau D; ANRS CO 13 HEPAVIH Study Group. Hepatitis C virus RNA quantitation in a nationwide French cohort of patients co-infected with HIV and HCV: should the same test be applied to all samples? J Virol Methods. 2012 Apr;181(1):131-3. doi: 10.1016/j.jviromet.2012.01.006. Epub 2012 Jan 20.
PubMed 22285372Solas C, Pambrun E, Winnock M, Salmon D, Poizot-Martin I, Dominguez S, Bani-Sadr F, Izopet J, Garraffo R, Peytavin G; ANRS CO-13 HEPAVIH Study Group. Ribavirin and abacavir drug interaction in HIV-HCV coinfected patients: fact or fiction? AIDS. 2012 Nov 13;26(17):2193-9. doi: 10.1097/QAD.0b013e32835763a4.
PubMed 22781224
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With Hepatitis C and Human Immunodeficiency Virus (Collaboration Inter Cohortes et Centres Cliniques de Sujets Co-infectés Par Les Virus de l'immunodéficence Humaine et de l'hépatite C)
- ClinicalTrials.gov ID
- NCT03324633
- Acronym / sponsor ID
- CO13Hepavih / ANRS CO13 Hepavih cohort
- Conditions
- HIV, Hepatitis C
- Keywords
- HIV, HCV, cohort, natural history, cure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Bristol-Myers Squibb, GlaxoSmithKline, Merck Serono International SA, Roche Pharma AG, Schering-Plough
- Study start
- Jun 2005
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Oct 2017 (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.
The ANRS CO13 HEPAVIH cohort is a prospective and multicentric cohort created in 2005 with the originality to cover two therapeutic domains of key importance, AIDS and hepatitis C. The cohort, is unique in Europe with more than 1800 participants followed over 10 years including quality of life and compliance to treatment data.
Detailed description
The cohort has been created in 2005 with the general objective to better define the natural history of HCV/HIV co-infection in terms of morbidity and mortality. Furthermore, the cohort aims to determine factors associated with morbidity and mortality and to better understand interactions between the two viruses and their respective treatments.
The ANRS CO13 Hepavih is currently composed of 28 french metropolitan clinical centers of infectious diseases and hepatogy diseases (mostly teaching hospital).
The period of patient inclusion has been divided in three distinct phases: the first phase (Phase 1) that started in 2005 and ended in 2008, was dedicated to the inclusion of adult HCV/HIV co-infected patients. The following inclusion phase (Phase 2) that concerns patients who received a triple-agent anti-HCV therapy including Boceprevir or Telaprevir, started in 2008 and ended in march 2016. The third one (Phase 3) focusing on patients initiating a DAA anti HCV treatment started in June 2014 and ended in November 2015. Regarding Phase 3, the specific objectives were organized into five thematic domains including clinic, virology, pharmacology, public health and methodology.
Since 31 march 2016, the inclusions are closed and 1,850 patients have been included. The ended of the follow-up is planned on the 31 december 2018.
At the inclusion and during the follow-up period (at least once a year or every 6 months in case of cirrhosis, until 2018 and probably also beyond that date), each HCV/HIV co-infected patient is offered a clinical examination as well as an interview. Additional self-questionnaires are filled by the included patients at the same time points (Social sciences data). The types of data collected from each co-infected patient included in the cohort are organized according to five major thematic classes: socio-demography and behavior, HIV characteristics, HCV characteristics, clinical relevant events, anthropometry, paraclinic data.
The ANRS CO13 HEPAVIH cohort has the purpose to become a facility for specific research regarding the physiopathological and therapeutic aspects of the HCV/HIV co-infection at the disposal of the entire scientific community.
In july 2016, the cohort has pusblished 29 originals articles and 10 as a part of national and European collaborations.
The ANRS CO13 HEPAVIH cohort has adopted functional governance. The Steering Committee, made-up of clinicians, methodologist, the sponsor as well as the cohort coordinators, is focused on logistic and operational aspects of the cohort. The Scientific Committee is the scientific decision-making organization, made-up with scientist experts in main research fields including methodology, hepathology, infectiology, pharmacology, virology and social science, and representatives of the ANRS and patient organizations. It assesses requests for the access to the cohort and provides advices on scientific, methodological and ethical aspects in order to ensure an effective scientific conduct of the research. The Steering Comitee meet once a month and the Scientific Comitee 2/3 times a year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Co-infected patients with HIV and HVC who are usually treated in one of the clinical centres of the ANRS CO13 Hepavih network (28 located in metropolitan France since 2014)
Key inclusion criteria (10 listed)
- Patients aged ≥18 years,
- Cover by a social security,
- Able to understand the consent conform.
- HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment)
- HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with protease inhibitor based treatment (PegIFN, Ribavirin and Telaprevir or Boceprevir) or having cleared HCV spontaneously in the absence of anti-HCV treatment
Key exclusion criteria (3 listed)
- Patients <18 years old
- So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
- Without an healthcare insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improve effectiveness and quality of medical care in Hepatitis C in HIV patients
Time frame: Through study completion : One visit/year for each participant + one additionnal visit every 6 months for patients with a cirhhosis
The CRFs compile clinical, biological, genetic and virological data : Clinical events, treatments (HIV, HVC, others), clinical exams (height, weight, hip and waist circumferences), virological : CD4, CD8, HIV RNA, HVC RNA (+genotype), HVB serology, liver functions tests and biology (fibroscan, fibrotest, ultrasound, transaminases, bilirubin, alkaline phosphatase, gamma GT,...), metabolic biochemistry (glycemia, insulin, cholesterol, creatinin, lipase). Patients also completed sociales sciences questionnaires (quality of life, depression,...) During the annual visit, samples are taken : blood for DNA, serum and plasma and are stocked in a biobank used for scientific projects.
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 2 Aug 2023.
- Results publication: PubMed 27317796Sogni P, Gilbert C, Lacombe K, Piroth L, Rosenthal E, Miailhes P, Gervais A, Esterle L, Chas J, Poizot-Martin I, Dominguez S, Simon A, Morlat P, Neau D, Zucman D, Bouchaud O, Lascoux-Combe C, Bani-Sadr F, Alric L, Goujard C, Vittecoq D, Billaud E, Aumaitre H, Boue F, Valantin MA, Dabis F, Salmon D, Wittkop L. All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus-coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13-HEPAVIH Cohort. Clin Infect Dis. 2016 Sep 15;63(6):763-770. doi: 10.1093/cid/ciw379. Epub 2016 Jun 17.
- Results publication: PubMed 27177169Marcellin F, Protopopescu C, Poizot-Martin I, Miailhes P, Esterle L, Wittkop L, Spire B, Bocquier A, Salmon-Ceron D, Dabis F, Carrieri MP; HEPAVIH ANRS CO13 Study Group. Short article: Fatigue in the long term after HCV treatment in HIV-HCV-coinfected patients: functional limitations persist despite viral clearance in patients exposed to peg-interferon/ribavirin-containing regimens (ANRS CO13-HEPAVIH cohort). Eur J Gastroenterol Hepatol. 2016 Sep;28(9):1003-7. doi: 10.1097/MEG.0000000000000664.
- Results publication: PubMed 27073179Marcellin F, Lions C, Rosenthal E, Roux P, Sogni P, Wittkop L, Protopopescu C, Spire B, Salmon-Ceron D, Dabis F, Carrieri MP; HEPAVIH ANRS CO13 Study Group*. No significant effect of cannabis use on the count and percentage of circulating CD4 T-cells in HIV-HCV co-infected patients (ANRS CO13-HEPAVIH French cohort). Drug Alcohol Rev. 2017 Mar;36(2):227-238. doi: 10.1111/dar.12398. Epub 2016 Apr 13.
- Results publication: PubMed 25778750Carrieri MP, Serfaty L, Vilotitch A, Winnock M, Poizot-Martin I, Loko MA, Lions C, Lascoux-Combe C, Roux P, Salmon-Ceron D, Spire B, Dabis F; ANRS CO13 HEPAVIH Study Group. Cannabis Use and Reduced Risk of Insulin Resistance in HIV-HCV Infected Patients: A Longitudinal Analysis (ANRS CO13 HEPAVIH). Clin Infect Dis. 2015 Jul 1;61(1):40-8. doi: 10.1093/cid/civ217. Epub 2015 Mar 16.
- Results publication: PubMed 25015913Marcellin F, Roux P, Loko MA, Lions C, Caumont-Prim A, Dabis F, Salmon-Ceron D, Spire B, Carrieri MP; HEPAVIH (ANRS CO13) Study Group. High levels of alcohol consumption increase the risk of advanced hepatic fibrosis in HIV/hepatitis C virus-coinfected patients: a sex-based analysis using transient elastography at enrollment in the HEPAVIH ANRS CO13 cohort. Clin Infect Dis. 2014 Oct 15;59(8):1190-2. doi: 10.1093/cid/ciu525. Epub 2014 Jul 11. No abstract available.
- Results publication: PubMed 26528903Salmon D, Bani-Sadr F, Gilbert C, Rosenthal E, Valantin MA, Simon A, Neau D, Morlat P, Loko MA, Wittkop L, Dabis F; ANRS CO13HEPAVIH study group. HCV viral load at baseline and at week 4 of telaprevir/boceprevir based triple therapies are associated with virological outcome in HIV/hepatitis C co-infected patients. J Clin Virol. 2015 Dec;73:32-35. doi: 10.1016/j.jcv.2015.10.010. Epub 2015 Oct 19.
- Results publication: PubMed 26372388ANRS CO13 HEPAVIH Cohort. Regression of liver stiffness after sustained hepatitis C virus (HCV) virological responses among HIV/HCV-coinfected patients. AIDS. 2015 Sep 10;29(14):1821-30. doi: 10.1097/QAD.0000000000000787.
- Results publication: PubMed 24166726Roux P, Lions C, Cohen J, Winnock M, Salmon-Ceron D, Bani-Sadr F, Sogni P, Spire B, Dabis F, Carrieri MP; ANRS-CO13-HEPAVIH Study Group. Impact of HCV treatment and depressive symptoms on adherence to HAART among HIV-HCV-coinfected patients: results from the ANRS-CO13-HEPAVIH cohort. Antivir Ther. 2014;19(2):171-8. doi: 10.3851/IMP2699. Epub 2013 Oct 28.
- Results publication: PubMed 24580042Marcellin F, Roux P, Winnock M, Lions C, Dabis F, Salmon-Ceron D, Loko MA, Spire B, Carrieri MP. Using patient-reported outcomes to improve the management of co-infection with HIV and HCV: the ANRS CO13 HEPAVIH cohort. Expert Rev Gastroenterol Hepatol. 2014 May;8(4):351-8. doi: 10.1586/17474124.2014.888949. Epub 2014 Mar 3.
- Results publication: PubMed 23978720Carrieri MP, Lions C, Sogni P, Winnock M, Roux P, Mora M, Bonnard P, Salmon D, Dabis F, Spire B; ANRS CO13 HEPAVIH Study Group. Association between elevated coffee consumption and daily chocolate intake with normal liver enzymes in HIV-HCV infected individuals: results from the ANRS CO13 HEPAVIH cohort study. J Hepatol. 2014 Jan;60(1):46-53. doi: 10.1016/j.jhep.2013.08.014. Epub 2013 Aug 24.
- Results publication: PubMed 24499953Bani-Sadr F, Loko MA, Pambrun E, Winnock M, Carrieri P, Gilbert C, Duvivier C, Bouchaud O, Gervais A, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Correlates of HIV sustained viral suppression in HIV/hepatitis C virus coinfected patients: possible role of the hepatitis C virus sustained viral response. AIDS. 2014 May 15;28(8):1155-60. doi: 10.1097/QAD.0000000000000218.
- Results publication: PubMed 23461846Winnock M, Bani-Sadr F, Pambrun E, Loko MA, Carrieri P, Neau D, Morlat P, Marchou B, Dabis F, Salmon D; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) CO13 HEPAVIH Study Group. Factors associated with guideline-based hepatitis C virus (HCV) treatment initiation in HIV/HCV-coinfected patients: role of comorbidities and physicians' perceptions. HIV Med. 2013 Aug;14(7):430-6. doi: 10.1111/hiv.12023. Epub 2013 Mar 5.
- Individual participant dataSharing planned: Yes. Data have been already shared in context of national, european and international collaborations : ANRS CO12 CIRVIR, ANRS HC EP25 PRETHEVIC, DHOS FIBROSTIC COHERE, … and also with industrial partners.
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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.
Dominique Salmon, MDPhD principal investigator
Assistance Publique des Hôpitaux de Paris -Université Paris Descartes
Linda Wittkop, MDPhD principal investigator
Inserm U1219 CHU de Bordeaux-Université de Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis C, run by ANRS, Emerging Infectious Diseases.
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 10 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: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Improve effectiveness and quality of medical care in Hepatitis C in HIV patients (time frame: Through study completion : One visit/year for each participant + one additionnal visit every 6 months for patients with a cirhhosis). 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 NCT03324633, which also lists 37 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 2 Aug 2023.