Clinical trial

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

Name

F150819001

Description

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.

Trial arms

Trial start

2015-10-01

Estimated PCD

2024-08-01

Trial end

2024-08-01

Status

Active (not recruiting)

Treatment

Anti-HIV Agents

Arms:

HIV-HBV co-infected

Other names:

Anti-retroviral therapy

Size

303

Primary endpoint

Change in liver fibrosis stage

From baseline to month 48

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 303, 'type': 'ACTUAL'}}

Updated at

2023-07-03

1 organization

1 product

8 indications

Organization

University of Alabama at Birmingham

Product

Anti-HIV Agents

Indication

HIV

Indication