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news.Ardea Biosciences has reported that the Medicines and Healthcare products Regulatory Agency in the United Kingdom has authorized a Phase IIa clinical trial evaluating RDEA806, a novel non-nucleoside reverse transcriptase inhibitor, in patients with human immunodeficiency virus, the causative agent of AIDS.
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The Phase IIa randomized, double-blind, proof-of-concept trial will be conducted in multiple European academic medical centers. The trial will evaluate the antiviral activity, pharmacokinetics, safety and tolerability of once daily and twice daily dose regimens of RDEA806 versus placebo in HIV-1 positive patients who are naive to antiretroviral treatment. The primary efficacy endpoint is the change from baseline in plasma viral load.
RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV infection.
Barry Quart, president and CEO of Ardea Biosciences, said: “We believe that RDEA806 has the potential to offer a new option for patients with HIV and are excited to move this novel compound into Phase II clinical testing. We expect to obtain results from this trial in the first quarter of 2008.”