Sponsor study identifier
interventional
24
1 country
1
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
August 2006
Actual (reported)This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
August 8, 2005
Actual (reported)August 9, 2005
Actual (reported)August 2006
Actual (reported)HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
Proportion of patients with undetectable HBV DNA in serum
Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion
Rate of emergence of lamivudine (LAM)-resistant HBV genotypes
Suppression of plasma HIV-RNA (< 50 copies/ml)
Changes in CD4+ /CD8+ cell counts
Academic Medical Center
Amsterdam, North Holland, 1105AZ, Netherlands
Joep M.A. Lange, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Kiat Ruxrungtham, MD PhD
HIVNAT Bangkok
Jan Prins, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First Submitted
August 8, 2005
First Posted
August 9, 2005
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
August 2006
Actual (reported)Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Last Updated
April 24, 2007
Record last verified: 2007-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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