- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Phnom Penh, Camboya
- Sihanouk Hospital Center of HOPE (SHCH), Cambodia
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Short-term progression to advanced liver fibrosis
Periodo de tiempo: 30 months
|
Proportion of patients who progress to advanced liver fibrosis (F≥3; LSM ≥9.5 kPa).
|
30 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Demographic characteristics
Periodo de tiempo: Baseline
|
Demographic baseline characteristics of the study participants
|
Baseline
|
Clinical characteristics
Periodo de tiempo: Baseline
|
Clinical baseline characteristics of the study participants
|
Baseline
|
Laboratory characteristics
Periodo de tiempo: Baseline
|
Laboratory baseline characteristics of the study participants
|
Baseline
|
Progression to cirrhosis
Periodo de tiempo: 30 months
|
Proportion of patients who progress to cirrhosis ((F=4, > 14 kPa)
|
30 months
|
Liver stiffness measurement
Periodo de tiempo: 30 months
|
Median Liver stiffness measurement increase per year
|
30 months
|
Changes in fibrosis stage scores
Periodo de tiempo: 30 months
|
Change in Metavir score (regression/progression, number of stages difference)
|
30 months
|
Diagnostic accuracy of non-invasive serum bio-markers: APRI
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Anja De Weggheleire, MD, Institute of Tropical Medicine, Antwerp, Belgium
- Investigador principal: An Sokkab, MD, Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Atributos de la enfermedad
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Enfermedades del HIGADO
- Enfermedad progresiva
- Hepatitis
- Hepatitis A
- Hepatitis C
Otros números de identificación del estudio
- HCV-Monitoring
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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