An observational study in Hepatitis B, HIV and Liver Cirrhosis, sponsored by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba. Status unknown at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-26.
Sponsored by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Observational
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.
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:
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 152 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-infected patients with chronic hepatitis B.
Exclusion Criteria:
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 14 years
Liver-related morbidity
Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up
Time frame: 14 years
Liver-related mortality
Proportion of patients who died due to liver-specific disease by the end of follow-up
Time frame: 14 years
Plan to share: Yes — Data will only be made available upon official request, pending approval by the Scientific Committee.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba