A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects
Sponsor study identifier
interventional
42
1 country
1
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
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.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
August 22, 2006
Actual (reported)August 24, 2006
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)Time to virological failure (DHSS definition)
week 144
incidence of AEs and laboratory abnormalities
Week 144
time to withdrawal due to AEs
Week 144
Change from baseline HIV RNA
weeks 72, 96, 120, and 144
Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml
at weeks 72, 96, 120, and 144
Change from baseline and change in ratio of CD4+ and CD8+ counts
at weeks 72, 96, 120, and 144
800mg ATC BID
800mg apricitabine twice daily orally for 96 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, 3121, Australia
Susan W Cox, Ph D
Avexa
42 participants (actual enrollment reported by the registry).
First Submitted
August 22, 2006
First Posted
August 24, 2006
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
June 23, 2011
Record last verified: 2011-06
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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