Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

NCT ID: NCT02344680

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2026-04-30

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.

Conditions

Human Immunodeficiency Virus; HBV; Fibrosis, Liver; Cirrhosis, Liver; Hepatocellular Carcinoma; Hepatitis Delta Virus; Alcoholic Hepatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with HIV-HBV co-infection

Adults with HIV-HBV co-infection who are receiving antiretroviral therapy

Anti-HIV Agents

Intervention Type: DRUG

Interventions

Anti-HIV Agents

Intervention Type: DRUG

Other Intervention Names

Anti-retroviral therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Michael Vinikoor

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Vinikoor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Lusaka Province, Zambia

Countries

Zambia

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Other Identifiers

K01TW009998

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-3000

Identifier Type: -

Identifier Source: org_study_id