A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine, Efavirenz and Didanosine Versus Continuation of Current Anti-Retroviral Regimen Delivered at Least Twice Daily
Sponsor study identifier
interventional
120
1 country
1
Study Start
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedPoor compliance is thought to be a major cause of treatment failure. The TEddI study is a randomised, multi-centre, open-label study in well-controlled treatment-experienced HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral therapy versus continuation of current anti-retroviral regimen delivered at least twice daily.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick 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.
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 16, 2005
Actual (reported)September 22, 2005
Actual (reported)- levels of adherence
- proportion of patients with treatment failure where treatment failure is defined
- HIV-1 RNA viral load of >400 copies/ml on two consecutive occasions more than one month apart, OR discontinuation of treatment for any reason (where subsequent therapy does not comply with the study regimen change guidelines outlined in section 3.3.3)
- proportion of patients with plasma HIV-RNA less than 50 copies/ml (using an ultrasensitive assay) at 24 and 48 weeks
- change from baseline in CD4 cell count at 24 and 48 weeks
- changes from baseline in subjects' quality of life at 24 and 48 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
407 Doctors
Sydney, New South Wales, 2010, Australia
David A Baker, MB ChB
407 Doctors
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
October 25, 2005
Record last verified: 2005-09
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Source: ClinicalTrials.gov.
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