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
|Condition or disease||Intervention/treatment|
|Hepatitis B HIV Liver Cirrhosis End Stage Liver Disease||Other: Routine care|
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|
|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|
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).
- 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
- 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
- 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.
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
|Centre hospitalier universitaire de Lyon|
|Lyon, France, 69317|
|Paris, France, 75010|
|Paris, France, 75012|
|Paris, France, 75020|
|Principal Investigator:||Anders Boyd, MPH, PhD||INSERM UMR S 1136|
|Principal Investigator:||Karine Lacombe, MD, PhD||INSERM UMR S 1136|