HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection
Completed
- Conditions
- HIVHepatitis-B
- Registration Number
- NCT00476723
- Brief Summary
The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- HIV positive
- hepatitis-B co-infected
- HBV/HIV therapy naive
- >18 years of age
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Exclusion Criteria
Unable to sign consent form.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy 48 weeks
- Secondary Outcome Measures
Name Time Method To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance. 48 weeks To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy 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 48 weeks
Trial Locations
- Locations (1)
HIV-NAT
🇹ðŸ‡Bangkok, Thailand