- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02628691
Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study.
Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
The study will be conducted in Sihanouk Hospital Center of Hope (SHCH) in Phnom Penh (Cambodia), more particularly within the ambulatory HIV clinic setting. SHCH is a non-governmental hospital providing comprehensive HIV care free of charge since March 2003, as part of the national antiretroviral (ARV) program. They dispose of an experienced HIV clinician, counselor and social worker team and several operational research studies were conducted within this setting.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. No formal sample size is being calculated. The final sample will comprise all patients fulfilling the inclusion criteria.
The data collected from the HCV-Epi study will be considered as the baseline visit for the HCV-Monitoring study. Thereafter, visits are planned at 6, 12, 18 and 24 months follow-up. These patient visits will, beyond the habitual HIV follow-up, integrate a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Phnom Penh, Cambodja
- Sihanouk Hospital Center of HOPE (SHCH), Cambodia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Male and females
- ≥18 years
- Documented HIV infection
- Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA
Absence of advanced liver disease or clinical signs of extra-hepatic disease:
- F0-F2 (< 9,5 kPa) established by transient elastography, and
- No clinical signs of extra-hepatic disease
- Not on HCV antiviral treatment
Exclusion Criteria:
- Currently on/or history of hepatitis C treatment
- Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography)
- Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
HCV coinfection with no-to-moderate fibrosis
|
A history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters will be performed.
Patients will also be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Short-term progression to advanced liver fibrosis
Tidsramme: 30 months
|
Proportion of patients who progress to advanced liver fibrosis (F≥3; LSM ≥9.5 kPa).
|
30 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Demographic characteristics
Tidsramme: Baseline
|
Demographic baseline characteristics of the study participants
|
Baseline
|
Clinical characteristics
Tidsramme: Baseline
|
Clinical baseline characteristics of the study participants
|
Baseline
|
Laboratory characteristics
Tidsramme: Baseline
|
Laboratory baseline characteristics of the study participants
|
Baseline
|
Progression to cirrhosis
Tidsramme: 30 months
|
Proportion of patients who progress to cirrhosis ((F=4, > 14 kPa)
|
30 months
|
Liver stiffness measurement
Tidsramme: 30 months
|
Median Liver stiffness measurement increase per year
|
30 months
|
Changes in fibrosis stage scores
Tidsramme: 30 months
|
Change in Metavir score (regression/progression, number of stages difference)
|
30 months
|
Diagnostic accuracy of non-invasive serum bio-markers: APRI
Tidsramme: 30 months
|
Predictive value of APRI to identify a shift from (≤F2) to advanced fibrosis (≥3)
|
30 months
|
Diagnostic accuracy of non-invasive serum bio-markers: FIB-4
Tidsramme: 30 months
|
Predictive value of FIB-4 to identify a shift from (≤F2) to advanced fibrosis (≥3)
|
30 months
|
Predictive factors for liver fibrosis progression
Tidsramme: 30 months
|
Factors associated with rapid fibrosis progression in HCV/HIV coinfected patients with initial mild to moderate fibrosis: age, gender, alcohol use, smoking, coffee consumption, comorbidities, liver enzymes, HCV viral load, HIV viral load, and ART exposure
|
30 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Anja De Weggheleire, MD, Institute of Tropical Medicine, Antwerp, Belgium
- Ledende efterforsker: An Sokkab, MD, Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
- Patologiske processer
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Sygdomsegenskaber
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Enterovirus infektioner
- Picornaviridae infektioner
- Leversygdomme
- Sygdomsprogression
- Hepatitis
- Hepatitis A
- Hepatitis C
Andre undersøgelses-id-numre
- HCV-Monitoring
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hepatitis C
-
Tripep ABInovio PharmaceuticalsUkendtKronisk hepatitis C virusinfektionSverige
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsTrukket tilbageKronisk hepatitis C virusinfektionIsrael
-
Hadassah Medical OrganizationUkendtKronisk hepatitis C virusinfektionIsrael
-
Beni-Suef UniversityAfsluttetKronisk hepatitis C virusinfektionEgypten
-
Trek Therapeutics, PBCAfsluttetKronisk hepatitis C | Hepatitis C genotype 1 | Hepatitis C (HCV) | Hepatitis C viral infektionForenede Stater, New Zealand
-
Trek Therapeutics, PBCAfsluttetKronisk hepatitis C | Hepatitis C (HCV) | Hepatitis C genotype 4 | Hepatitis C viral infektionForenede Stater
-
Humanity and Health Research CentreBeijing 302 HospitalAfsluttetKronisk hepatitis C-infektionKina
-
AbbVieAfsluttetKronisk hepatitis C | Hepatitis C (HCV) | Hepatitis C genotype 1a
-
AbbVie (prior sponsor, Abbott)AfsluttetKronisk hepatitis C | Hepatitis C genotype 1 | Hepatitis C (HCV)Forenede Stater, Australien, Canada, Frankrig, Tyskland, New Zealand, Puerto Rico, Spanien, Det Forenede Kongerige
-
AbbVieAfsluttetHepatitis C virus | Kronisk hepatitis C-virus
Kliniske forsøg med Liver fibrosis progression
-
Centre Hospitalier Universitaire de NīmesAfsluttetKroniske nyresygdomme | Akut nyreskadeFrankrig
-
Atos Medical ABRoyal Brisbane and Women's Hospital; Princess Alexandra Hospital, Brisbane... og andre samarbejdspartnereAfsluttet
-
Baylor College of MedicineAfsluttet
-
PharmaNest, IncIcahn School of Medicine at Mount Sinai; Chinese University of Hong Kong; Imperial College London og andre samarbejdspartnereIkke rekrutterer endnuMetabolisk dysfunktion-associeret steatotisk leversygdomForenede Stater, Hong Kong, Det Forenede Kongerige, Spanien
-
Copenhagen Academy for Medical Education and SimulationBispebjerg Hospital; Danish Cancer Society; Herlev Hospital; Region Capital... og andre samarbejdspartnereIkke rekrutterer endnuSund og rask | Kolorektal cancer
-
Rhode Island HospitalIkke rekrutterer endnu
-
University of Kansas Medical CenterAfsluttet
-
Atos Medical ABInstituto de Cancer Dr ArnaldoIkke rekrutterer endnu
-
Jennifer StaabRekruttering
-
University of VictoriaChildhood Obesity FoundationUkendtFedme | Ernæringsforstyrrelser | Kropsvægt | Børns adfærd | Sundhedsadfærd | Børns fedmeCanada