Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

Active, not recruiting

• Conditions: Alcoholic Hepatitis; Fibrosis, Liver; Human Immunodeficiency Virus; HBV; Cirrhosis, Liver; Hepatocellular Carcinoma; Hepatitis Delta Virus
• Interventions: Drug: Anti-HIV Agents

• Registration Number: NCT02344680
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Study Start: 2015-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 303

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with HIV-HBV co-infection	Anti-HIV Agents	Adults with HIV-HBV co-infection who are receiving antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
Change in liver fibrosis stage	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia (CIDRZ); 🇿🇲 Lusaka, Zambia