CompletedPhase 3Phase 4ACTRN12605000436673

Virological and clinical anti-HBV efficacy of tenofovir in antiretroviral naive patients with HIV/HBV co-infection

A randomised mulitcentre trial of tenofovir (TDF) vs lamividine (LAM) vs TDF/LAM in antiretroviral naive subjects with HIV/HBV conifection over 48 weeks.

Sponsor

National Centre in HIV Epidemiology and Clincial Research

Enrollment

51 participants

Start Date

Jan 26, 2004

Study Type

Interventional

Conditions

HIV Hepatitis B Coinfection

Summary

A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naive HBV mono-infected subjects (Substudy A1)

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests how well the drug tenofovir works against hepatitis B in patients who also have HIV and have not yet started HIV treatment. It is open to adults aged 18 to 70. Participation involves taking the study medication and regular blood tests to track both infections.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Tenofovir, Lamivudine over 48 weeks

Locations(1)

NSW, Australia

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ACTRN12605000436673