- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361541
Determination of HCV Prevalence in a HIV Patient Cohort in Phnom Penh, Cambodia (HCV-Epi)
Determination of Hepatitis C Prevalence, Genetic Diversity and Treatment Eligibility in an HIV Patient Cohort in Phnom Penh, Cambodia
Hepatitis C (HCV) is an important global public health problem, disproportionately affecting HIV positive populations. Asia and Africa account for most of the co-infection burden, but access to HCV screening and treatment is still very limited. It is expected though, with the recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should become a feasible option in the near future.
Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest HIV cohorts of the country, followed in an ambulatory settings. In this cohort, the prevalence of HCV co-infection will be determined, as well as HCV genotype diversity and the severity of liver disease. The researcher will also explore the performance of simple blood tests/panels as predictors of significant fibrosis and/or cirrhosis.
Patients will attend two study-visits. All adult patients of the HIV patient cohort of SHCH will be proposed HCV testing during their next HIV follow-up consultation, following the latest algorithm of the Centre for Disease Control (CDC) (May 2013). Anamnesis and clinical examination will focus, additionally to routine practice, on presence of general and HCV liver-disease related features. Laboratory analyses will include basic HIV tests (CD4), and tests for liver function such as Hepatitis B surface antigen (HbsAg) .
During the following routine HIV follow-up consultation, the results of HCV testing will be explained to the patient. If the patient is HCV negative, his/her study participation ends here. If currently infected with HCV, the clinician will repeat the HCV liver-disease (extra-hepatic & hepatic) related anamnesis and clinical examination, and prescribe additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver stiffness measurements.
Study Overview
Detailed Description
Hepatitis C (HCV) is an important global public health problem, disproportionally affecting HIV positive populations. Asia and Africa account for most of the co-infection burden, but access to HCV screening and treatment is still very limited. The high cost and complexity of current diagnostic and treatment algorithms are major bottlenecks and the linked lack of accurate HCV prevalence estimates and treatment-need data do not allow for robust treatment advocacy and program planning. Cambodia is not an exception.
It is expected though, with the recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should become a feasible option in the near future. Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest HIV cohorts of the country, and it is planning to engage in HCV treatment from 2014 2015 onwards, with a double objective of direct patient benefit and catalyst role at national level, as in the past when starting its antiretroviral (ARV) program.
Within this specific setting, the researchers plan to determine the prevalence of HCV co-infection, HCV genotype diversity and severity of liver disease in this HIV patient cohort, followed in an ambulatory setting. The researchers will also explore the performance of simple blood tests/panels as predictors of significant fibrosis and/or cirrhosis .
The current HCV diagnostic procedures (and tools), as applied in this study, are too expensive and resource-demanding to allow for scalability in resource limited settings. Thus, the researchers plan to set up during this study a biobank with samples of a clinically well described HIV patient population. These samples should allow constituting a well-balanced panel for evaluation of future 'more scalable' HCV diagnostic tools.
Patients will attend two study-visits. All adult patients of the HIV cohort will be proposed HCV testing during their next regular HIV follow-up consultation. HCV testing will follow the latest algorithm of the Centre for Disease Control (CDC) (May 2013). During this same consultation, anamnesis and clinical examination will focus, additionally to routine practice ,on presence of general and HCV liver-disease related features. Laboratory analyses will also include basic HIV (CD4), and tests for liver function such as Hepatitis B surface antigen (HbsAg).
During the following routine HIV follow-up consultation (2-3 months later), the results of HCV testing will be explained to the patient. If the patient is HCV negative, his/her study participation ends here. If currently infected with Hepatitis C, the clinician will repeat the HCV liver-disease (extra-hepatic & hepatic) related anamnesis and clinical examination and prescribe additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver stiffness measurements.
The biobank will be set up with left over biological samples (whole blood plasma and serum) and comprehensive clinical information of all patients who give additional consent for this scope. Both biological samples and clinical information will be coded, to ensure confidentiality.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Phnom Penh, Cambodia
- Sihanouk Hospital Center of HOPE (SHCH), Cambodia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (> or = 18 years old)
- Documented HIV positive
- In regular HIV care follow-up (min. 2 consultations in the last six months prior to the study)
- Willing and able to provide written informed consent
Exclusion Criteria:
• HIV patients with currently taking Hepatitis C treatment or with a history of prior hepatitis C treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HCV screening
All adult patients of an existing HIV cohort
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HCV antibody screening, liver function tests, full blood count and HbsAg will performed.
Additional blood samples will be taken for further HCV diagnostic work-out (polymerase chain reaction (PCR) and genotyping).
For patients with current HCV infection, liver ultrasound, transient elastography - Firbroscan and further lab analysis will be performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprevalence of HCV infection
Time Frame: Baseline
|
Seroprevalence of HCV infection in the HIV patient cohort
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of current HCV infection
Time Frame: Baseline
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Proportion of currently infected with HCV among the HCV-IgG positive HIV patients
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Baseline
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Proportion of HCV false-positives
Time Frame: Baseline
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Proportion of HCV biologically false-positives among HCV-IgG positive screening
|
Baseline
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HCV genotypes
Time Frame: Baseline
|
Proportions of different HCV genotypes
|
Baseline
|
Severity of liver disease in HCV patients
Time Frame: Baseline
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To determine the severity of liver disease by transient elastography in this coinfected cohort
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Baseline
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HCV diagnostic accuracy
Time Frame: Baseline
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To compare the diagnostic accuracy of commonly available blood panel tests for fibrosis staging in this coinfected cohort, with liver stiffness measurement (considered as reference standard).
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Baseline
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Collaborators and Investigators
Investigators
- Study Director: Anja De Weggheleire, MD, Institute of Tropical Medicine, Antwerp, Belgium
- Principal Investigator: An Sokkab, MD, Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCV-Epi
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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