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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476723
• Other study ID #: HIV-NAT 032
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2006
• Last updated: June 4, 2010
• Start date: April 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2010
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• HIV positive

• hepatitis-B co-infected

• HBV/HIV therapy naive

• >18 years of age

Exclusion Criteria:

Unable to sign consent form.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis-B
• HIV

Locations

Country	Name	City	State
Thailand	HIV-NAT	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Kirby Institute, Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy		48 weeks	No
Secondary	To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.		48 weeks	No
Secondary	To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy		48 weeks	No
Secondary	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		48 weeks	No

External Links

•   The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)