Skip to main content
OpenTrials
Completed

NCT Number: NCT02344680

Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Adenocarcinoma Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Hepatitis Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chemically-Induced Disorders Cirrhosis, Liver Communicable Diseases Digestive System Diseases Digestive System Neoplasms Fibrosis Fibrosis, Liver Genital Diseases HBV HIV Infections Hepatitis Hepatitis D Hepatitis Delta Virus Hepatitis, Alcoholic Hepatitis, Viral, Human Hepatocellular Carcinoma Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Lusaka Province, 34681, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-HIV Agents

Drug

Other names: Anti-retroviral therapy

Primary outcomes

  1. Reduction in Liver Fibrosis Stage

    Time frame: From baseline to 10 years of follow-up

    Based on transient elastography, we calculated the number and proportion of participants with at least significant fibrosis at their first measure who regressed to minimal-no fibrosis during follow-up. This outcome excluded participants with no-minimal fibrosis at enrollment.

Secondary outcomes

  1. Prevalence of Significant Liver Fibrosis (Metavir F2 or Greater)

    Time frame: At enrollment

    Proportion of participants with median liver stiffness based on transient elastography of >=7 kPa

  2. 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

  3. Incidence of Hepatocellular Carcinoma

    Time frame: From baseline to 10 years of follow-up

    Number of new cases of hepatocellular carcinoma during follow-up

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2015
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.