Study was withdrawn owing to Sponsor decision
A Phase 3, Open Label 96-week Extension Study of the Safety of Apricitabine in Treatment-experienced HIV-1 Infected Patients Who Have Completed Protocol AVX-301 or AVX-302 or Who Have Met the Criteria for Open-label Access to ATC Because of Virological Failure/Lack of Response
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will examine the long term safety of apricitabine in HIV-1 infected patients from studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and consequently wish to withdraw early from studies AVX-301 or AVX-302.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 27, 2008
Actual (reported)May 29, 2008
Actual (reported)May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The number, type and severity of SAEs occuring during the study
Week 96
apricitabine
Initially 1200mg apricitabine twice daily orally. Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mike Saag, Professor
UAB Centre for AIDS Research, Birmingham, Alabama, 35294-2050, USA
Susan W Cox, PhD
Avexa Ltd
0 participants (actual enrollment reported by the registry).
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
QoL and Adherence to One-pill Once-a-day HAART
Contact the study team to confirm eligibility.
Primary Completion
May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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