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

November 15, 2006
June 4, 2010
April 2005
December 2007   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00476723 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

PBMC

Non-Probability Sample

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

  • HIV
  • Hepatitis-B
Not Provided
1
HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Unable to sign consent form.

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00476723
HIV-NAT 032
Yes
Prof. Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • Kirby Institute
  • Ministry of Health, Thailand
Principal Investigator: Kiat Ruxrungtham, MD, MSc HIV-NAT, The Thai Red Cross AIDS Research Centre
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

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