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
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 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 16, 2013