- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476723
HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection
Generation of HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection Receiving HBV-active Antiretroviral Therapy
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Bangkok, Thailand
- HIV-NAT
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- HIV positive
- hepatitis-B co-infected
- HBV/HIV therapy naive
- >18 years of age
Exclusion Criteria:
Unable to sign consent form.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.
Time Frame: 48 weeks
|
48 weeks
|
To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy
Time Frame: 48 weeks
|
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
|
48 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kiat Ruxrungtham, MD, MSc, HIV-NAT, The Thai Red Cross AIDS Research Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIV-NAT 032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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