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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00476723

Enrollment

Registered

2007-05-22

Start date

2005-04-30

Completion date

2007-12-31

Last updated

2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis-B, HIV

Keywords

HIV infection, Hepatitis coinfection

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Unable to sign consent form.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.	48 weeks
To identify emergence of cytotoxic T lymphocyte (CTL) escape mutants following anti-HBV therapy	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	48 weeks

Countries

Thailand

Outcome results