Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

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Brief Title

Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

Official Title

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

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.
    

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 Type

Observational


Primary Outcome

Change in liver fibrosis stage

Secondary Outcome

 Incidence of hepatocellular carcinoma

Condition

Human Immunodeficiency Virus

Intervention

Anti-HIV Agents

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

400

Start Date

October 2015

Completion Date

August 2024

Primary Completion Date

August 2024

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael J Vinikoor, MD, , 

Location Countries

Zambia

Location Countries

Zambia

Administrative Informations


NCT ID

NCT02344680

Organization ID

F150819001

Secondary IDs

1K01TW009998

Responsible Party

Principal Investigator

Study Sponsor

University of Alabama at Birmingham

Collaborators

 Fogarty International Center of the National Institute of Health

Study Sponsor

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


Verification Date

May 2021