A Phase II Multicenter, Open-label, Randomized, Parallel Group, Study of Bevirimat in HIV-1 Positive Patients to Evaluate the Safety, Efficacy, and Pharmacokinetics of MPC-4326 Administered as Monotherapy for 14 Days and as Part of an Optimized Background Regimen for up to 72 Weeks.
Sponsor study identifier
Secondary identifiers
interventional
32
1 country
4
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
December 2009
Actual (reported)To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an initial treatment response will have the option to continue MPC-4326 in combination with an Optimized Backround Regimen for a maximum of 72 weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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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.
August 25, 2009
Actual (reported)August 27, 2009
Actual (reported)November 2009
Actual (reported)December 2009
Actual (reported)Change in HIV-1 viral load from baseline to day 15
15 days
To evaluate safety and tolerability
72 weeks
Patients will be treated with MPC-4326 200mg monotherapy for 14 days. Once the Day 15 viral load results become available, patients, who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.
Patients will be treated with MPC-4326, 300 mg monotherapy for 14 days. Once the Day 15 viral load results become available patients who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.
AIDS Research Initiative
Darlinghurst, New South Wales, 2010, Australia
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales, 2010, Australia
Andrew Beelen, MD
Myrexis Inc.
First Submitted
August 25, 2009
First Posted
August 27, 2009
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
December 2009
Actual (reported)Last Updated
January 6, 2010
Record last verified: 2010-01
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Source: ClinicalTrials.gov.
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