Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia

HIV Clinical Trial

— HCV-Monitoring  

Official title:

Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02628691
• Other study ID #: HCV-Monitoring
• Status: Terminated
• Phase: N/A
• First received: November 25, 2015
• Last updated: August 22, 2017
• Start date: December 17, 2015
• Est. completion date: July 12, 2017

Study information

• Verified date: August 2017
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: July 12, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV
• Liver Diseases

Intervention

Other:
• Liver fibrosis progression
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.

Locations

Country	Name	City	State
Cambodia	Sihanouk Hospital Center of HOPE (SHCH), Cambodia	Phnom Penh

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Sihanouk Hospital Center of HOPE, University Hospital, Antwerp

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term progression to advanced liver fibrosis	Proportion of patients who progress to advanced liver fibrosis (F=3; LSM =9.5 kPa).	30 months
Secondary	Demographic characteristics	Demographic baseline characteristics of the study participants	Baseline
Secondary	Clinical characteristics	Clinical baseline characteristics of the study participants	Baseline
Secondary	Laboratory characteristics	Laboratory baseline characteristics of the study participants	Baseline
Secondary	Progression to cirrhosis	Proportion of patients who progress to cirrhosis ((F=4, > 14 kPa)	30 months
Secondary	Liver stiffness measurement	Median Liver stiffness measurement increase per year	30 months
Secondary	Changes in fibrosis stage scores	Change in Metavir score (regression/progression, number of stages difference)	30 months
Secondary	Diagnostic accuracy of non-invasive serum bio-markers: APRI	Predictive value of APRI to identify a shift from (=F2) to advanced fibrosis (=3)	30 months
Secondary	Diagnostic accuracy of non-invasive serum bio-markers: FIB-4	Predictive value of FIB-4 to identify a shift from (=F2) to advanced fibrosis (=3)	30 months
Secondary	Predictive factors for liver fibrosis progression	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