CompletedPhase 2

Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

Thailand24 participantsStarted 2005-04

Plain-language summary

Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. HBsAg positive and
✓. HBc core IgM antibody negative and
✓. the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.

What they're measuring

HBV DNA suppression to levels below the limit of detection (<400 copies/ml)

Timeframe: week 48

Trial details

NCT IDNCT00476463

SponsorThe HIV Netherlands Australia Thailand Research Collaboration

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

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