Hepatocellular Carcinoma Clinical Trial
Official title:
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study
Verified date | June 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Zambia | Centre for Infectious Disease Research in Zambia (CIDRZ) | Lusaka |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH) |
Zambia,
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* Note: There are 36 references in all — Click here to view all references
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 |
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