The Phase IIa randomized, double-blind, placebo-controlled trial evaluated the antiviral activity, pharmacokinetics, safety and tolerability of once- and twice-daily oral dosing regimens of RDEA806 versus placebo in 48 HIV-positive patients who were naive to antiretroviral treatment.
Approximately nine out of 12 patients in each of four cohorts received RDEA806. The primary efficacy end point was the change from baseline in plasma viral load. Results from all four cohorts showed a median reduction in plasma viral load at nadir of 1.8 – 2 log copies/ml.
There were no serious adverse events, premature discontinuations and drug-related rash reported in any cohort. The incidence of central nervous system side effects was similar between drug and placebo.
Barry Quart, president and CEO of Ardea, said: “We look forward to further evaluating RDEA806 and are on track to begin a Phase IIb study comparing once daily doses of RDEA806 to efavirenz (Sustiva, Stocrin) in first-line patients receiving background treatment with Truvada (emtricitabine and tenofovir disoproxil fumarate), in the third quarter of 2008.”