ITMO public health
Last update : 09/13/2018 | Version : 3 | ID : 3626
| General | |
| Identification | |
| Detailed name | Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C |
| Sign or acronym | ANRS C013 HEPAVIH |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ClinicalTrials : NCT03324633 ; CPP : CG/LG/CC 2005-466 |
| General Aspects | |
| Medical area |
Immunology Infectious diseases |
| Health determinants |
Lifestyle and behavior |
| Keywords | Adults, disease carriers, cured, treatment, co-infection |
| Scientific investigator(s) (Contact) | |
| Name of the director | Wittkop |
| Surname | Linda |
| Address |
VIH, Hépatites Virales et comorbidités : épidémiologie clinique et santé publique / Multimorbidity and Public Health in Patients with HIV or Hepatitis (MORPH3Eus) CMG-EC de l’INSERM U1219 / ANRS Université de Bordeaux ISPED 146, rue Léo Saignat – CS61292 33076 Bordeaux cedex FRANCE |
| Phone | +33 (0)5 57 57 13 92 |
| linda.wittkop@u-bordeaux.fr | |
| Unit | INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, équipe Morpheus, CMG-EC |
| Organization | Inserm |
| Name of the director | Salmon |
| Surname | Dominique |
| Phone | +33 (0) 1 42 34 79 56 |
| dominique.salmon@aphp.fr | |
| Unit | Services des Maladies Infectieuses et Tropicales |
| Organization | Assistance Publique des Hôpitaux de Paris - Hôpitaux Paris Centre, Université Paris Descartes |
| Name of the director | Sogni |
| Surname | Philippe |
| Address | Hôpital Cochin |
| philippe.sogni@aphp.fr | |
| Unit | Service d'Hépatologie |
| Organization | Assistance Publique des Hôpitaux de Paris - Hôpitaux Paris Centre, Université Paris Descarte, Inserm |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | ANRS, INSERM, Laboratoires Glaxo-SmithKline, Roche, Schering Plough et Janssen |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | ANRS - AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | Esterle |
| Surname | Laure |
| Address |
VIH, Hépatites Virales et comorbidités : épidémiologie clinique et santé publique / Multimorbidity and Public Health in Patients with HIV or Hepatitis (MORPH3Eus) CMG-EC de l’INSERM U1219 / ANRS Université de Bordeaux ISPED 146, rue Léo Saignat – CS61292 33076 Bordeaux cedex FRANCE |
| Phone | +(33)5 57 57 92 71 |
| laure.esterle@u-bordeaux.fr | |
| Unit | INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, équipe Morpheus, CMG-EC |
| Organization | Inserm |
| Name of the contact | ANRS |
| Address | 101 rue de Tolbiac 75013 Paris |
| Unit | Service de recherches fondamentales, cliniques et thérapeutiques sur les Hépatites virales |
| Organization | ANRS |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Dates and inclusions duration: Phase 1: 2005-2008 (3 years) Phase 2: 2011-2014 (3 years) |
| Database objective | |
| Main objective |
Short term:
- Describe patient's characteristics - Analyze factors associated to a treatment of hepatitis C: beginning of the treatment, continuation or stop of the treatment. - Validate the field performance of not-invasive markers of hepatic fibrosis. Mid-term: - Realize an observational study of the evolution of hepatitis during an anti-VHC treatment, in an antiviral situation - Study the clinical and biological tolerance to the different treatments. - Study the impact of the observance of the treatment anti HIV and the life quality of patients. Long term: Study the natural history of chronic hepatitis, in particular at the stage of cirrhosis. - Analyze the factors associated to the evolution to fibrosis, to a decompensated hepatic disease or an hepatocellular carcinoma. - Evaluate the effects of antiretroviral agents on the evolution of not-treated hepatitis - Study the potential interactions between different virus of hepatitis |
| Inclusion criteria | Adults infected by HIV virus carriers of VHC or cured after anti-VHC treatment, or spontaneously healed without anti-VHC treatment or benefiting from an anti-VHC tritherapies. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Pathology | B24 - Unspecified human immunodeficiency virus [HIV] disease |
| B15-B19 - Viral hepatitis | |
| Gender |
Male Woman Other |
| Geography area |
National |
| Detail of the geography area | French multi-centers cohort (28 centers) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2006 |
| Date of last collection (YYYY or MM/YYYY) | 09/2022 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1849 in june 2018 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at inclusion and during the follow-up. Information collected during the clinical examination: weigh, height, waist and hips circumference |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Clinical examination at inclusion and during the follow-up. Information collected during the clinical examination: weigh, height, waist and hips circumference |
| Paraclinical data (detail) | Radiology, evaluation of the hepatic fibrosis |
| Biological data (detail) | Blood check |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma |
| Details of biobank content | Serum bank, plasma bank, DNA bank, total blood, tissues bank in a non-systematic way |
| Health parameters studied |
Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Self-questionnaire: filled from a paper questionnaire. Interviews: filled from a paper questionnaire .Clinical examination: manual data entry .Biological examination: manual data entry |
| Classifications used | --- |
| Quality procedure(s) used | Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | Annual or bi-annual, specific according to the anti-VHC treatment |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | Liste publications COHORTE ANRS CO13 HEPAVIH 20180830.pdf |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=HEPAVIH+OR+ANRS+CO13+OR+%28cohere+AND+%28hiv+OR+AIDS%29%29 |
| Description | List of publications in Pubmed |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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