HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection

The HIV Netherlands Australia Thailand Research Collaboration36 enrolled

Overview

The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.

Longitudinal study of circulating and intra-hepatic HBV-specific T-cell immunity in the setting of a randomised, controlled, international, multi-centre outpatient trial. The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens. Study population: Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viremia and are willing to start antiretroviral therapy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Hepatitis-B

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV positive * hepatitis-B co-infected * HBV/HIV therapy naive * \>18 years of age Exclusion Criteria: Unable to sign consent form.

Locations (1)

HIV-NAT

Bangkok, Thailand

Outcomes

Primary Outcomes

To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy

Time frame: 48 weeks

Secondary Outcomes

To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.

Time frame: 48 weeks

To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy

Time frame: 48 weeks

To determine the effect of HIV-1 co-infection and anti-HBV T-cell responses on clearance of free virions and HBV reservoirs using viral dynamic parameters and direct quantification of HBV hepatic reservoirs

Time frame: 48 weeks

Data from ClinicalTrials.gov

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