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Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02344680
Collaborator
Fogarty International Center of the National Institute of Health (NIH), National Institutes of Health (NIH) (NIH)
303
Enrollment
1
Location
106
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of antiretroviral drugs in the prevention and/or reduction of liver disease.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anti-HIV Agents

Detailed Description

Among HIV-infected individuals 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 a currently approved and active research study taking place in Lusaka Urban district - HIV/HBV co-infection in IeDEA-SA (NCT02060162, clinicaltrials.gov) - 800 consecutive HIV-infected adults were screened for possible causes of liver disease and 12% were diagnosed with chronic hepatitis B virus (HBV) co-infection. HBV co-infected patients were more likely to have evidence of liver disease; however, ascertainment of critical long-term outcomes of HIV-HBV patients was not part of the study. 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 Zambian HIV-HBV patients. In the proposed study, the investigators will determine the risk factors for liver disease among Zambian HIV-HBV co-infected patients, and assess the long-term effectiveness of Ministry of Health (MOH)-recommended antiretroviral drugs in the prevention and/or reduction of HIV-HBV liver disease. This study will provide useful clinical and epidemiologic information to health policymakers in Zambia and throughout the region and may lead to improvements in the care of HIV-HBV patients. Further, it will strengthen collaboration between Zambian institutions and strengthen local capacity in HBV diagnosis and management.

Study Design

Study Type:
Observational
Actual Enrollment :
303 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
HIV-HBV co-infected

HIV-HBV co-infected patients receiving anti-retroviral therapy

Drug: Anti-HIV Agents
Other Names:
  • Anti-retroviral therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in liver fibrosis stage [From baseline to month 48]

      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

    1. Incidence of hepatocellular carcinoma [From baseline to month 48]

      Liver cancer screening at baseline and during follow-up

    2. Prevalence of significant liver fibrosis (Metavir F2 or greater) [At enrollment]

      Measure of liver fibrosis using AST-to-platelet ratio index (APRI), Fibrosis 4 (FIB-4) and transient elastography

    3. Risk factors for persistent HBV viremia 9Measure HBV DNA at baseline and month 12 and determine patient characteristics associated with unsuppressed HBV after 12 months of treatment) [Month 12]

      Measure HBV DNA at baseline and month 12 and determine patient characteristics associated with unsuppressed HBV after 12 months of treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 years or older

    • HIV-infected

    • HBV-infected, 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Infectious Disease Research in Zambia (CIDRZ) Lusaka Zambia 34681

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Michael J Vinikoor, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Michael Vinikoor, Assistant Professor, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT02344680
    Other Study ID Numbers:
    • F150819001
    • 1K01TW009998
    First Posted:
    Jan 26, 2015
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Hepatitis A
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Hepatitis D
    Hepatitis
    Liver Cirrhosis
    Hepatitis, Alcoholic
    Fibrosis
    Anti-HIV Agents

    Study Results

    No Results Posted as of Jun 2, 2022