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

NCT ID: NCT00476723

Last Updated: 2010-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Hepatitis-B

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Unable to sign consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirby Institute

OTHER_GOV

Sponsor Role collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

Responsible Party

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HIV-NAT

Principal Investigators

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Kiat Ruxrungtham, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

HIV-NAT, The Thai Red Cross AIDS Research Centre

Locations

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HIV-NAT

Bangkok, , Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.hivnat.org

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

Other Identifiers

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HIV-NAT 032

Identifier Type: -

Identifier Source: org_study_id

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