HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection
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|ClinicalTrials.gov Identifier: NCT00476723|
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : June 7, 2010
|Condition or disease|
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|
|Actual Enrollment :||36 participants|
|Official Title:||Generation of HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection Receiving HBV-active Antiretroviral Therapy|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476723
|Principal Investigator:||Kiat Ruxrungtham, MD, MSc||HIV-NAT, The Thai Red Cross AIDS Research Centre|