Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

NCT02344680 | Active Not Recruiting

• 2 other identifiers: IRB-3000K01TW009998
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in liver fibrosis stage

  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 Outcomes (3)

• Incidence of hepatocellular carcinoma

  From baseline to 10 years of follow-up

• Prevalence of significant liver fibrosis (Metavir F2 or greater)

  At enrollment

• Prevalence of persistent HBV viremia: Measure HBV DNA at month 24

  Month 24

Study Arms (1)

Adults with HIV-HBV co-infection

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

Drug: Anti-HIV Agents

Interventions

Anti-HIV Agents DRUG

Also known as: Anti-retroviral therapy

Adults with HIV-HBV co-infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

400 adults with HIV-HBV coinfection

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Fogarty International Center of the National Institute of Health: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Lusaka Province, 34681, Zambia

Location

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• The Zambian National Health Research Bill, 2013

  BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Liver Cirrhosis; Carcinoma, Hepatocellular; Hepatitis D; Hepatitis, Alcoholic

Interventions

Anti-HIV Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Michael J Vinikoor, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 26, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)