French HIV-HBV Cohort (COVViB)

April 25, 2018 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69317
        • Centre Hospitalier Universitaire de Lyon
      • Paris, France, 75012
        • Hopital Saint-Antoine
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75010
        • Hôpital Saint-Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-infected patients with chronic hepatitis B.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 years
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
14 years
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
14 years
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
14 years
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
14 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 years
Liver-related mortality
Time Frame: 14 years
Proportion of patients who died due to liver-specific disease by the end of follow-up
14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Collaborators

ANRS, Emerging Infectious Diseases
Sidaction

Investigators

  • Principal Investigator: Anders Boyd, MPH, PhD, INSERM UMR S 1136
  • Principal Investigator: Karine Lacombe, MD, PhD, INSERM UMR S 1136

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

March 31, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA 49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will only be made available upon official request, pending approval by the Scientific Committee.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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