HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
Kirby Institute
Ministry of Health, Thailand
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476723
First received: November 15, 2006
Last updated: June 4, 2010
Last verified: June 2010
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Purpose
The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Generation of HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection Receiving HBV-active Antiretroviral Therapy |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
PBMC
| Enrollment: | 36 |
| Study Start Date: | April 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV/Hepatitis B coinfected patients using at least one hepatitis active medications in HAART regimen
Criteria
Inclusion Criteria:
- HIV positive
- hepatitis-B co-infected
- HBV/HIV therapy naive
- >18 years of age
Exclusion Criteria:
Unable to sign consent form.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476723
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476723
Locations
| Thailand | |
| HIV-NAT | |
| Bangkok, Thailand | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Kirby Institute
Ministry of Health, Thailand
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD, MSc | HIV-NAT, The Thai Red Cross AIDS Research Centre |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Kiat Ruxrungtham, HIV-NAT |
| ClinicalTrials.gov Identifier: | NCT00476723 History of Changes |
| Other Study ID Numbers: | HIV-NAT 032 |
| Study First Received: | November 15, 2006 |
| Last Updated: | June 4, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
HIV infection Hepatitis coinfection |
ClinicalTrials.gov processed this record on March 03, 2015