French HIV-HBV Cohort

NCT02889094 | Unknown DMC

• 1 other identifier: IMEA 49
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatitis B; HIV; Liver Cirrhosis; End Stage Liver Disease

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Liver-related morbidity

  14 years

• Liver-related mortality

  14 years

Study Arms (1)

HIV-HBV co-infected individuals

No interventions will be administered. Individuals will be undergoing routine care.

Other: Routine care

Interventions

Routine care OTHER

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).

HIV-HBV co-infected individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients with chronic hepatitis B.

You may qualify if:

• Completed follow-up in at least one previous study phase of the French HIV-HBV Cohort
• Obtained signed written informed consent

You may not qualify if:

• Refusal to participate
• Any severe physical, clinical or mental condition preventing participation

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Sidaction: collaborator

Study Sites (4)

Centre hospitalier universitaire de Lyon

Lyon, 69317, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Related Publications (3)

• 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.

  PMID: 26153669 BACKGROUND

• 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.

  PMID: 24752996 BACKGROUND

• 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. doi: 10.1097/01.aids.0000200537.86984.0e.

  PMID: 16439876 BACKGROUND

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.

MeSH Terms

Conditions

Hepatitis B; Liver Cirrhosis; End Stage Liver Disease

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency

Study Officials

• Anders Boyd, MPH, PhD

  INSERM UMR S 1136

  PRINCIPAL INVESTIGATOR

• Karine Lacombe, MD, PhD

  INSERM UMR S 1136

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 5, 2016
• Study Start: October 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: September 1, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (4)