Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

June 30, 2023 updated by: Michael Vinikoor, University of Alabama at Birmingham

Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study

In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of antiretroviral drugs in the prevention and/or reduction of liver disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Among HIV-infected individuals in Africa, liver disease is a neglected area of investigation but is anticipated to become increasingly common as patients live longer due to antiretroviral therapy. In a currently approved and active research study taking place in Lusaka Urban district - HIV/HBV co-infection in IeDEA-SA (NCT02060162, clinicaltrials.gov) - 800 consecutive HIV-infected adults were screened for possible causes of liver disease and 12% were diagnosed with chronic hepatitis B virus (HBV) co-infection. HBV co-infected patients were more likely to have evidence of liver disease; however, ascertainment of critical long-term outcomes of HIV-HBV patients was not part of the study. Building on these preliminary results and addressing the need to study HIV-HBV during a longer duration of follow-up, the current protocol will focus exclusively on Zambian HIV-HBV patients. In the proposed study, the investigators will determine the risk factors for liver disease among Zambian HIV-HBV co-infected patients, and assess the long-term effectiveness of Ministry of Health (MOH)-recommended antiretroviral drugs in the prevention and/or reduction of HIV-HBV liver disease. This study will provide useful clinical and epidemiologic information to health policymakers in Zambia and throughout the region and may lead to improvements in the care of HIV-HBV patients. Further, it will strengthen collaboration between Zambian institutions and strengthen local capacity in HBV diagnosis and management.

Study Type

Observational

Enrollment (Actual)

303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia, 34681
        • Centre for Infectious Disease Research in Zambia (CIDRZ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

400 HIV-HBV patients

Description

Inclusion Criteria:

  • Age 18 years or older
  • HIV-infected
  • HBV-infected, defined as any single positive HBsAg assay
  • Naïve to antiretroviral therapy or currently participating in HIV/HBV co-infection in IeDEA-SA

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Planning to relocate out of Lusaka district

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-HBV co-infected
HIV-HBV co-infected patients receiving anti-retroviral therapy
Drug: Anti-HIV Agents
Other Names:
  • Anti-retroviral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver fibrosis stage
Time Frame: From baseline to month 48
Measure of liver fibrosis using AST-to-platelet ratio index (APRI), Fibrosis 4 (FIB-4) and transient elastography. Ascertainment of potential risk factors including demographics, alcohol use, HIV-related biomarkers, HBV DNA, hepatitis delta virus, and other factors.
From baseline to month 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hepatocellular carcinoma
Time Frame: From baseline to month 48
Liver cancer screening at baseline and during follow-up
From baseline to month 48
Prevalence of significant liver fibrosis (Metavir F2 or greater)
Time Frame: At enrollment
Measure of liver fibrosis using AST-to-platelet ratio index (APRI), Fibrosis 4 (FIB-4) and transient elastography
At enrollment
Risk factors for persistent HBV viremia 9Measure HBV DNA at baseline and month 12 and determine patient characteristics associated with unsuppressed HBV after 12 months of treatment)
Time Frame: Month 12
Measure HBV DNA at baseline and month 12 and determine patient characteristics associated with unsuppressed HBV after 12 months of treatment
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Michael J Vinikoor, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimated)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F150819001
  • 1K01TW009998 (U.S. NIH Grant/Contract)

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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