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
  Purpose

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


Condition Phase
HIV
Hepatitis-B
Phase 3

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

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 April 17, 2014