French HIV-HBV Cohort

HIV Clinical Trial

— COVViB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02889094
• Other study ID #: IMEA 49
• Status: Active, not recruiting
• First received: August 25, 2016
• Last updated: April 25, 2018
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2018
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: September 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV
• Liver Cirrhosis
• Liver Diseases

Intervention

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).

Locations

Country	Name	City	State
France	Centre hospitalier universitaire de Lyon	Lyon
France	Hôpital Saint-Antoine	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Tenon	Paris

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

References & Publications (3)

Boyd 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. — View Citation

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. — View Citation

Lacombe 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 years
Primary	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	14 years
Primary	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	14 years
Primary	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	14 years
Primary	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	14 years
Secondary	Liver-related morbidity	Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up	14 years
Secondary	Liver-related mortality	Proportion of patients who died due to liver-specific disease by the end of follow-up	14 years