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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 July 2023 |
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Main ID: |
NCT02344680 |
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Date of registration:
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12/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
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Scientific title:
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Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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303 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02344680 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Michael J Vinikoor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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HBV
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Human Immunodeficiency Virus
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Alcoholic Hepatitis
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Hepatitis Delta Virus
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Cirrhosis, Liver
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Fibrosis, Liver
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Intervention(s)
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Drug: Anti-HIV Agents
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Primary Outcome(s)
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Change in liver fibrosis stage
[Time Frame: From baseline to month 48]
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Secondary Outcome(s)
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Prevalence of significant liver fibrosis (Metavir F2 or greater)
[Time Frame: At enrollment]
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Incidence of hepatocellular carcinoma
[Time Frame: From baseline to month 48]
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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)
[Time Frame: Month 12]
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Secondary ID(s)
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1K01TW009998
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F150819001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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