Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With HIV and HCV

HIV Clinical Trial

— CO13Hepavih  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324633
• Other study ID #: ANRS CO13 Hepavih cohort
• Status: Completed
• Start date: June 2005
• Est. completion date: December 2022

Study information

• Verified date: August 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The cohort, is unique in Europe with more than 1800 participants followed over 10 years including quality of life and compliance to treatment data.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1850
• Est. completion date: December 2022
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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)

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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Bristol-Myers Squibb, GlaxoSmithKline, Merck Serono International SA, Roche Pharma AG, Schering-Plough

References & Publications (34)

Abravanel F, Raymond S, Pambrun E, Winnock M, Bonnard P, Sogni P, Trimoulet P, Dabis F, Salmon-Ceron D, Izopet J; ANRS CO13 HEPAVIH Study Group. HIV-1 tropism and liver fibrosis in HIV-HCV co-infected patients. PLoS One. 2012;7(11):e50289. doi: 10.1371/jo — View Citation

ANRS 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. — View Citation

Bani-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 r — View Citation

Cales P, Halfon P, Batisse D, Carrat F, Perre P, Penaranda G, Guyader D, d'Alteroche L, Fouchard-Hubert I, Michelet C, Veillon P, Lambert J, Weiss L, Salmon D, Cacoub P. Comparison of liver fibrosis blood tests developed for HCV with new specific tests in — View Citation

Carrieri MP, Cohen J, Salmon-Ceron D, Winnock M. Coffee consumption and reduced self-reported side effects in HIV-HCV co-infected patients during PEG-IFN and ribavirin treatment: results from ANRS CO13 HEPAVIH. J Hepatol. 2012 Mar;56(3):745-7. doi: 10.101 — View Citation

Carrieri MP, Cohen J, Winnock M, Salmon D. Chocolate intake, depression, and clinical progression in HIV-HCV coinfected patients: still more questions than answers. Arch Intern Med. 2010 Sep 27;170(17):1607; author reply 1608-9. doi: 10.1001/archinternmed — View Citation

Carrieri 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 indivi — View Citation

Carrieri MP, Protopopescu C, Marcellin F, Rosellini S, Wittkop L, Esterle L, Zucman D, Raffi F, Rosenthal E, Poizot-Martin I, Salmon-Ceron D, Dabis F, Spire B; ANRS CO13 HEPAVIH Study Group. Protective effect of coffee consumption on all-cause mortality o — View Citation

Carrieri 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: — View Citation

Carrieri MP, Sogni P, Cohen J, Loko MA, Winnock M, Spire B; HEPAVIH Study Group. Elevated coffee consumption and reduced risk of insulin resistance in HIV-HCV coinfected patients (HEPAVIH ANRS CO-13). Hepatology. 2012 Nov;56(5):2010. doi: 10.1002/hep.2581 — View Citation

Knight R, Roux P, Vilotitch A, Marcellin F, Rosenthal E, Esterle L, Boue F, Rey D, Piroth L, Dominguez S, Sogni P, Salmon-Ceron D, Spire B, Carrieri MP; ANRS CO13-HEPAVIH Study Group. Significant reductions in alcohol use after hepatitis C treatment: resu — View Citation

Loko MA, Bani-Sadr F, Valantin MA, Lascoux-Combe C, Fontaine H, Bonnard P, Gervais A, Bouchaud O, Garipuy D, Quertainmont Y, Vittecoq D, Tehrani MS, Winnock M, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Antiretroviral therapy and sustained virolog — View Citation

Loko MA, Bani-Sadr F, Winnock M, Lacombe K, Carrieri P, Neau D, Morlat P, Serfaty L, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Impact of HAART exposure and associated lipodystrophy on advanced liver fibrosis in HIV/HCV-coinfected patients. J Vira — View Citation

Loko MA, Salmon D, Carrieri P, Winnock M, Mora M, Merchadou L, Gillet S, Pambrun E, Delaune J, Valantin MA, Poizot-Martin I, Neau D, Bonnard P, Rosenthal E, Barange K, Morlat P, Lacombe K, Gervais A, Rouges F, See AB, Lascoux-Combe C, Vittecoq D, Goujard — View Citation

Marcellin 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 H — View Citation

Marcellin 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 reb — View Citation

Marcellin F, Protopopescu C, Esterle L, Wittkop L, Piroth L, Aumaitre H, Bouchaud O, Goujard C, Vittecoq D, Dabis F, Salmon-Ceron D, Spire B, Roux P, Carrieri MP; ANRS CO13-HEPAVIH Study Group. Short article: Anger and quality of life in patients co-infec — View Citation

Marcellin 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 pat — View Citation

Marcellin 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 pa — View Citation

Marcellin 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. 20 — View Citation

Piroth L, Wittkop L, Lacombe K, Rosenthal E, Gilbert C, Miailhes P, Carrieri P, Chas J, Poizot-Martin I, Gervais A, Dominguez S, Neau D, Zucman D, Billaud E, Morlat P, Aumaitre H, Lascoux-Combe C, Simon A, Bouchaud O, Teicher E, Bani-Sadr F, Alric L, Vitt — View Citation

Roux P, Cohen J, Lascoux-Combe C, Sogni P, Winnock M, Salmon-Ceron D, Spire B, Dabis F, Carrieri MP; ANRS-CO13-HEPAVIH study group. Determinants of the underreporting of alcohol consumption by HIV/HCV co-infected patients during face-to-face medical inter — View Citation

Roux P, Fugon L, Winnock M, Salmon-Ceron D, Lacombe K, Sogni P, Spire B, Dabis F, Carrieri MP; ANRS-CO-13-HEPAVIH Study Group. Positive impact of hepatitis C virus (HCV) treatment on antiretroviral treatment adherence in human immunodeficiency virus-HCV c — View Citation

Roux 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 — View Citation

Salmon 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 — View Citation

Salmon D, Bani-Sadr F, Loko MA, Stitou H, Gervais A, Durant J, Rosenthal E, Quertainmont Y, Barange K, Vittecoq D, Shoai-Tehrani M, Alvarez M, Winnock M, Trinchet JC, Dabis F, Sogni P. Insulin resistance is associated with a higher risk of hepatocellular — View Citation

Salmon-Ceron D, Cohen J, Winnock M, Roux P, Sadr FB, Rosenthal E, Martin IP, Loko MA, Mora M, Sogni P, Spire B, Dabis F, Carrieri MP; HEPAVIH group. Engaging HIV-HCV co-infected patients in HCV treatment: the roles played by the prescribing physician and — View Citation

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, Aumaitr — View Citation

Solas 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 1 — View Citation

Trimoulet 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 t — View Citation

Ulveling D, Le Clerc S, Cobat A, Labib T, Noirel J, Laville V, Coulonges C, Carpentier W, Nalpas B, Heim MH, Poynard T, Cerny A, Pol S, Bochud PY, Dabis F, Theodorou I, Levy Y, Salmon D, Abel L, Dominguez S, Zagury JF; HEPAVIH ANRS CO13 Cohort Study Group — View Citation

Winnock 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 vi — View Citation

Winnock M, Bani-Sadr F, Pambrun E, Loko MA, Lascoux-Combe C, Garipuy D, Rosenthal E, Carrieri P, Dabis F, Salmon D. Prevalence of immunity to hepatitis viruses A and B in a large cohort of HIV/HCV-coinfected patients, and factors associated with HAV and H — View Citation

Yaya I, Roux P, Marcellin F, Salmon-Ceron D, Carrieri MP. Unstable Housing Still a Barrier to Receiving HCV Treatment in France (ANRS CO13 HEPAVIH Cohort). Dig Dis Sci. 2017 Oct;62(10):2943-2944. doi: 10.1007/s10620-017-4703-y. Epub 2017 Aug 5. No abstrac — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion : One visit/year for each participant + one additionnal visit every 6 months for patients with a cirhhosis