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Completed

NCT Number: NCT00476723

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

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

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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Genital Diseases HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Hepatitis-B Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HIV-NAT

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Unable to sign consent form.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.

    Time frame: 48 weeks

  2. To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy

    Time frame: 48 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Kirby Institute
  • Ministry of Health, Thailand

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 22, 2007
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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