In the phase IIb study, HIV-infected patients failing their current antiretroviral therapy will receive oral bevirimat or placebo once daily for three months in combination with background antiretroviral therapy.
Efficacy endpoints of the study will include reduction in viral load after 14 days of functional monotherapy and after three months of dosing. If doses up to 600mg are evaluated and all three dosage groups are expanded, the total number of patients in the trial would be approximately 144, including 108 patients receiving bevirimat and 36 patients receiving placebo.
“With the benefit of the results of our phase IIa study, we have been able to focus on a dose range that we believe will provide maximum antiviral benefit to patients. In the phase IIb trial, we plan to test these doses of bevirimat in combination with approved HIV drugs as part of an optimized regimen in patients failing treatment due to drug resistance. The goal of this study is to select the most appropriate dose to take into pivotal phase III testing,” said Dr Samuel Ackerman, Panacos’ president and CEO.