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French HIV-HBV Cohort (COVViB)

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ClinicalTrials.gov Identifier: NCT02889094
Recruitment Status : Active, not recruiting
First Posted : September 5, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sidaction
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Brief Summary:
The overarching purpose of this study is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.

Condition or disease Intervention/treatment
Hepatitis B HIV Liver Cirrhosis End Stage Liver Disease Other: Routine care

Detailed Description:

The French HIV-HBV Cohort is an observational, non-interventional study including 308 HIV-infected patients with chronic HBV infection (HBsAg-positive serology >6 months) in seven clinical centers. Patients were recruited in 2002-2003 and followed prospectively every three to twelve months, during two phases, until 2010-2011. Extensive information on a variety of HIV- and HBV-related parameters were collected during these study visits.

This particular study aims to extend follow-up of the French HIV-HBV Cohort using a different type of design. Patients who completed at least one study phase of the French HIV-HBV Cohort are selected for participation. Patients continuing follow-up at a participating clinical center are asked to undergo their routine clinical visit, during which time medical data from the years since last cohort visit until their routine visit are extracted. For those who died, information from the years since last cohort visit until death will be collected.

The primary objective for this cohort extension is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.

The following secondary objectives are as follows:

  • To establish the extent of persistent viremia (PV) of HBV, quantified either in serum or within the hepatocyte
  • To understand whether this persistence effects clinically-relevant serological outcomes (i.e. HBeAg and HBsAg seroclearance and seroconversion along with HBsAg quantification) after prolonged follow-up
  • To quantify the evolution of liver fibrosis using non-invasive methods and, in a small subset of patients, liver biopsies, while investigating the virological and immunological factors associated with its progression and regression
  • To describe the causes of liver-related and non-liver-related morbidity and mortality and the direct effect of persistent HBV DNA replication on these outcomes

Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Multi-center Study Evaluating Persistence of Hepatitis B Virus Replication, Long-term Prognostic Indicators and Their Clinical Relevance in Patients Co-infected With the Human Immunodeficiency Virus and Chronic Hepatitis B
Study Start Date : October 2016
Actual Primary Completion Date : March 31, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HIV-HBV co-infected individuals
No interventions will be administered. Individuals will be undergoing routine care.
Other: Routine care
Routine care recommended for patients co-infected with HIV and hepatitis B virus (per European Association for the Study of the Liver and European AIDS Clinical Society guidelines).




Primary Outcome Measures :
  1. HBV DNA replication [ Time Frame: 14 years ]
    Proportion of patients with detectable HBV DNA levels, as determined by a commercially-available PCR assay (>60 international units/mL), at the beginning and end of follow-up

  2. HBeAg-seroclearance [ Time Frame: 14 years ]
    Proportion of hepatitis B "e" antigen (HBeAg)-positive patients who lose HBeAg-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up

  3. HBsAg-seroclearance [ Time Frame: 14 years ]
    Proportion of patients who lose hepatitis B surface antigen (HBsAg)-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up

  4. Liver fibrosis (FibroTest) [ Time Frame: 14 years ]
    Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroTest (non-invasive biochemical score) with a level >= 0.59, at the beginning and end of follow-up

  5. Liver fibrosis (FibroScan) [ Time Frame: 14 years ]
    Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroScan (transient elastography) with a level >= 7.6 kPa, at the beginning and end of follow-up


Secondary Outcome Measures :
  1. Liver-related morbidity [ Time Frame: 14 years ]
    Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up

  2. Liver-related mortality [ Time Frame: 14 years ]
    Proportion of patients who died due to liver-specific disease by the end of follow-up


Biospecimen Retention:   Samples Without DNA

Serum and plasma samples will be stored for quantification of biochemical parameters.

Liver tissue (for individuals receiving liver biopsies) will be stored for quantification of intracellular HBV DNA replication.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected patients with chronic hepatitis B.
Criteria

Inclusion Criteria:

  • HBsAg seropositivity for >6 months (at initial cohort inclusion)
  • HIV-positive serology confirmed with Western blot (at initial cohort inclusion)
  • Karnofsky score >70 (at initial cohort inclusion)
  • Age ≥18 years old (at initial cohort inclusion)
  • Completed follow-up in at least one previous study phase of the French HIV-HBV Cohort
  • Obtained signed written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Any severe physical, clinical or mental condition preventing participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889094


Locations
France
Centre hospitalier universitaire de Lyon
Lyon, France, 69317
Hôpital Saint-Louis
Paris, France, 75010
Hôpital Saint-Antoine
Paris, France, 75012
Hôpital Tenon
Paris, France, 75020
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sidaction
Investigators
Principal Investigator: Anders Boyd, MPH, PhD INSERM UMR S 1136
Principal Investigator: Karine Lacombe, MD, PhD INSERM UMR S 1136

Publications:
Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT02889094     History of Changes
Other Study ID Numbers: IMEA 49
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will only be made available upon official request, pending approval by the Scientific Committee.

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Liver Cirrhosis
End Stage Liver Disease
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Liver Failure
Hepatic Insufficiency