HBV-Specific T-Cell Immunity in Individuals With HIV/HBV co-Infection - Full Text View

Sponsors and Collaborators:	The HIV Netherlands Australia Thailand Research Collaboration The National Centre in HIV Epidemiology and Clinical Research Ministry of Health, Thailand
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00476723

Purpose

The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.

Condition	Phase
HIV Hepatitis-B	Phase III

MedlinePlus related topics: AIDS Hepatitis Hepatitis B

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Generation of HBV-Specific T-Cell Immunity in Individuals With HIV/HBV co-Infection Receiving HBV-Active Antiretroviral Therapy

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

Biospecimen Description:

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

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

The National Centre in HIV Epidemiology and Clinical Research

Ministry of Health, Thailand

Investigators

Principal Investigator:

Kiat Ruxrungtham, MD, MSc

HIV-NAT, The Thai Red Cross AIDS Research Centre

More Information

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

Responsible Party:	HIV-NAT ( Prof. Kiat Ruxrungtham )
Study ID Numbers:	HIV-NAT 032
Study First Received:	November 15, 2006
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00476723
Health Authority:	Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

HIV infection
Hepatitis coinfection

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
HIV Infections

Acquired Immunodeficiency Syndrome
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Infection
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009