Hepatitis BCOVViBNCT02889094
French HIV-HBV Cohort
An observational study of Hepatitis B and HIV, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, HIV, Liver Cirrhosis
- What is being tested?
- Routine care
- How many people
- 152 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2016to Sep 2018
- 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: HIV-infected patients with chronic hepatitis B.
Who may be able to join
- 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
Who cannot join
- Refusal to participate
- Any severe physical, clinical or mental condition preventing participation
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre hospitalier universitaire de Lyon
Lyon, 69317
Hôpital Saint-Louis
Paris, 75010
Hôpital Saint-Antoine
Paris, 75012
Hôpital Tenon
Paris, 75020
About this study
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
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.
Read the 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
- Conditions
- Hepatitis B, HIV, Liver Cirrhosis, End Stage Liver Disease
- Being tested
- Routine care
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
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).
| Study group | Role | What they receive |
|---|---|---|
| HIV-HBV co-infected individuals | No interventions will be administered. Individuals will be undergoing routine care. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA replication
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
Measured: 14 years
HBeAg-seroclearance
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
Measured: 14 years
HBsAg-seroclearance
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
Measured: 14 years
Liver fibrosis (FibroTest)
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
Measured: 14 years
Liver fibrosis (FibroScan)
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
Measured: 14 years
Secondary outcomes (2)
Liver-related morbidity
Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up
Measured: 14 years
Liver-related mortality
Proportion of patients who died due to liver-specific disease by the end of follow-up
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion31 Mar 2018
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Sidaction
- Responsible party
- Sponsor
- Investigators
- Anders Boyd, MPH, PhD, Principal investigator, INSERM UMR S 1136Karine Lacombe, MD, PhD, Principal investigator, INSERM UMR S 1136
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889094
- Sponsor's protocol ID
- IMEA 49
- Acronym
- COVViB
- Status last verified
- Apr 2018
- First submitted
- 25 Aug 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will only be made available upon official request, pending approval by the Scientific Committee.
Publications
Boyd A, Gozlan J, Miailhes P, Lascoux-Combe C, Cam MS, Rougier H, Zoulim F, Girard PM, Lacombe K. Rates and determinants of hepatitis B 'e' antigen and hepatitis B surface antigen seroclearance during long-term follow-up of patients coinfected with HIV and hepatitis B virus. AIDS. 2015 Sep 24;29(15):1963-73. doi: 10.1097/QAD.0000000000000795.
PubMed 26153669Boyd A, Gozlan J, Maylin S, Delaugerre C, Peytavin G, Girard PM, Zoulim F, Lacombe K. Persistent viremia in human immunodeficiency virus/hepatitis B coinfected patients undergoing long-term tenofovir: virological and clinical implications. Hepatology. 2014 Aug;60(2):497-507. doi: 10.1002/hep.27182. Epub 2014 Jun 20.
PubMed 24752996Lacombe K, Massari V, Girard PM, Serfaty L, Gozlan J, Pialoux G, Mialhes P, Molina JM, Lascoux-Combe C, Wendum D, Carrat F, Zoulim F. Major role of hepatitis B genotypes in liver fibrosis during coinfection with HIV. AIDS. 2006 Feb 14;20(3):419-27. doi: 10.1097/01.aids.0000200537.86984.0e.
PubMed 16439876
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02889094
- Acronym / sponsor ID
- COVViB / IMEA 49
- Conditions
- Hepatitis B, HIV, Liver Cirrhosis, End Stage Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Sidaction
- Study start
- Oct 2016
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-HBV co-infected individuals | – | Other: Routine careNo interventions will be administered. Individuals will be undergoing routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients with chronic hepatitis B.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate
- Any severe physical, clinical or mental condition preventing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine careRoutine 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). | Other | HIV-HBV co-infected individuals |
Primary outcome
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
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
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
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
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
2 secondary outcomes
Liver-related morbidity
Time frame: 14 years
Liver-related mortality
Time frame: 14 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 26153669Boyd A, Gozlan J, Miailhes P, Lascoux-Combe C, Cam MS, Rougier H, Zoulim F, Girard PM, Lacombe K. Rates and determinants of hepatitis B 'e' antigen and hepatitis B surface antigen seroclearance during long-term follow-up of patients coinfected with HIV and hepatitis B virus. AIDS. 2015 Sep 24;29(15):1963-73. doi: 10.1097/QAD.0000000000000795.
- Background: PubMed 24752996Boyd A, Gozlan J, Maylin S, Delaugerre C, Peytavin G, Girard PM, Zoulim F, Lacombe K. Persistent viremia in human immunodeficiency virus/hepatitis B coinfected patients undergoing long-term tenofovir: virological and clinical implications. Hepatology. 2014 Aug;60(2):497-507. doi: 10.1002/hep.27182. Epub 2014 Jun 20.
- Background: PubMed 16439876Lacombe K, Massari V, Girard PM, Serfaty L, Gozlan J, Pialoux G, Mialhes P, Molina JM, Lascoux-Combe C, Wendum D, Carrat F, Zoulim F. Major role of hepatitis B genotypes in liver fibrosis during coinfection with HIV. AIDS. 2006 Feb 14;20(3):419-27. doi: 10.1097/01.aids.0000200537.86984.0e.
- Individual participant dataSharing planned: Yes. Data will only be made available upon official request, pending approval by the Scientific Committee.
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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.
Anders Boyd, MPH, PhD principal investigator
INSERM UMR S 1136
Karine Lacombe, MD, PhD principal investigator
INSERM UMR S 1136
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and HIV, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 4 sites in France.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
HBV DNA replication (time frame: 14 years). The study lists 5 primary outcomes in all. 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 NCT02889094, which also lists 3 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 26 Apr 2018.