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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 09, 2014