Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02344680
• Other study ID #: F150819001
• Secondary ID: 1K01TW009998
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 303
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcoholic Hepatitis
• Cirrhosis, Liver
• Fibrosis
• Fibrosis, Liver
• HBV
• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis Delta Virus
• Hepatitis, Alcoholic
• Hepatocellular Carcinoma
• HIV Infections
• Human Immunodeficiency Virus
• Liver Cirrhosis

Intervention

Drug:
• Anti-HIV Agents

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia (CIDRZ)	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)

Country where clinical trial is conducted

Zambia, 

References & Publications (36)

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The Zambian National Health Research Bill, 2013

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 month 48
Secondary	Incidence of hepatocellular carcinoma	Liver cancer screening at baseline and during follow-up	From baseline to month 48
Secondary	Prevalence of significant liver fibrosis (Metavir F2 or greater)	Measure of liver fibrosis using AST-to-platelet ratio index (APRI), Fibrosis 4 (FIB-4) and transient elastography	At enrollment
Secondary	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)	Measure HBV DNA at baseline and month 12 and determine patient characteristics associated with unsuppressed HBV after 12 months of treatment	Month 12

External Links

•   Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill (U.S.A.)