Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

June 5, 2025 updated by: Michael Vinikoor, University of Alabama at Birmingham

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

A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-depth mechanistic studies and clinical trials of novel HBV cure drugs.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Among people with HIV 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 Lusaka, Zambia, we previously (NCT02060162, clinicaltrials.gov) described that HIV-HBV co-infection was the most important liver risk factor. However, in that study, only very short-term outcomes could be assessed. 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 people with HIV-HBV in Zambia. Zambia is an ideal site for this research as it has ~12% HIV prevalence and 6% HBsAg-positivity among adults nationwide. In fact, ~70% of people with HIV-HBV globally reside in Africa. In the proposed study, we will obtain consent from people with HIV-HBV to participate in an observational cohort study with up to 10 years of follow-up. Standard of care antiviral therapies will be received by participants. More in-depth analysis of liver and HBV viral and serological outcomes will occur. Screening for liver cancer will also occur. This study will provide useful clinical and epidemiological information to health policymakers in Zambia and beyond. It will also provide a platform for the training of health workers in Zambia in HBV clinical 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 adults with HIV-HBV coinfection

Description

Inclusion Criteria:

  • Age 18 years or older
  • Living with HIV infection
  • Living with active HBV infection, 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
Adults with HIV-HBV co-infection
Adults with HIV-HBV co-infection who are receiving antiretroviral 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 10 years of follow-up
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 10 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of significant liver fibrosis (Metavir F2 or greater)
Time Frame: At enrollment
Proportion of participants with liver fibrosis by non-invasive measures (AST-to-platelet ratio index, Fibrosis 4, or transient elastography)
At enrollment
Prevalence of persistent HBV viremia: Measure HBV DNA at month 24
Time Frame: Month 24
Proportion of participants with measure of HBV DNA above detection at month 24
Month 24
Incidence of hepatocellular carcinoma
Time Frame: From baseline to 10 years of follow-up
Number of new cases of hepatocellular carcinoma during follow-up
From baseline to 10 years of follow-up

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 (Actual)

October 1, 2015

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

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)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-3000
  • K01TW009998 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

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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