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Determination of HCV Prevalence in a HIV Patient Cohort in Phnom Penh, Cambodia

NCT02361541 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3045

Last updated 2016-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C
  • HIV

Interventions

PROCEDURE

HCV screening

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.

Sponsors & Collaborators

  • Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia

    collaborator UNKNOWN

  • Universiteit Antwerpen

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Anja De Weggheleire, MD · Institute of Tropical Medicine, Antwerp, Belgium

  • An Sokkab, MD · Sihanouk Hospital Center of HOPE (SHCH), Cambodia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Cambodia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361541 on ClinicalTrials.gov