HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2006

Last Updated Date

June 4, 2010

Start Date ^ICMJE

April 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00476723 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection

Official Title ^ICMJE

Generation of HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection Receiving HBV-active Antiretroviral Therapy

Brief Summary

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

PBMC

Sampling Method

Non-Probability Sample

Study Population

HIV/Hepatitis B coinfected patients using at least one hepatitis active medications in HAART regimen

Condition ^ICMJE

HIV
Hepatitis-B

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV positive
hepatitis-B co-infected
HBV/HIV therapy naive
>18 years of age

Exclusion Criteria:

Unable to sign consent form.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT00476723

Other Study ID Numbers ^ICMJE

HIV-NAT 032

Has Data Monitoring Committee

Yes

Responsible Party

Prof. Kiat Ruxrungtham, HIV-NAT

Study Sponsor ^ICMJE

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators ^ICMJE

Kirby Institute
Ministry of Health, Thailand

Investigators ^ICMJE

Principal Investigator:

Kiat Ruxrungtham, MD, MSc

HIV-NAT, The Thai Red Cross AIDS Research Centre

Information Provided By

The HIV Netherlands Australia Thailand Research Collaboration

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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