- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02889094
French HIV-HBV Cohort (COVViB)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Lyon, Frankrig, 69317
- Centre Hospitalier Universitaire de Lyon
-
Paris, Frankrig, 75012
- Hôpital Saint-Antoine
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Paris, Frankrig, 75020
- Hopital Tenon
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Paris, Frankrig, 75010
- Hopital Saint-Louis
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
HIV-HBV co-infected individuals
No interventions will be administered.
Individuals will be undergoing 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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
HBV DNA replication
Tidsramme: 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
|
14 years
|
HBeAg-seroclearance
Tidsramme: 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
|
14 years
|
HBsAg-seroclearance
Tidsramme: 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
|
14 years
|
Liver fibrosis (FibroTest)
Tidsramme: 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
|
14 years
|
Liver fibrosis (FibroScan)
Tidsramme: 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
|
14 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Liver-related morbidity
Tidsramme: 14 years
|
Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up
|
14 years
|
Liver-related mortality
Tidsramme: 14 years
|
Proportion of patients who died due to liver-specific disease by the end of follow-up
|
14 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Anders Boyd, MPH, PhD, INSERM UMR S 1136
- Ledende efterforsker: Karine Lacombe, MD, PhD, INSERM UMR S 1136
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Leversvigt
- Leverinsufficiens
- Patologiske processer
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Hepatitis, viral, menneskelig
- Hepadnaviridae infektioner
- DNA-virusinfektioner
- Enterovirus infektioner
- Picornaviridae infektioner
- Fibrose
- Leversygdomme
- Slutstadie leversygdom
- Hepatitis B
- Hepatitis
- Hepatitis A
- Levercirrhose
Andre undersøgelses-id-numre
- IMEA 49
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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