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Kaletra + Raltegravir PROGRESS Study
  Abbott's PROGRESS Study of combining Kaletra plus raltegravir is fully enrolled, data is expected to be presented in the second half of 2009. The following information was provided by Abbott.
Kaletra and Isentress

♦ The PROGRESS study is a 96-week evaluation of the safety and efficacy of Kaletra (lopinavir/ritonavir) in combination with Isentress (raltegravir) in antiretroviral-naïve subjects, compared to Kaletra and Truvada (emtricitabine and tenofovir disoproxil fumarate).
♦ The PROGRESS study combines Kaletra, the most studied protease inhibitor, with Isentress, a leader in the new integrase inhibitor treatment class.
♦ The PROGRESS study will assess the safety, tolerability and antiviral activity of Kaletra and Isentress, compared to a traditional triple drug combination of Kaletra, plus two nucleoside analogues, Truvada (emtricitabine and tenofovir disoproxil fumarate).
♦ The primary efficacy endpoint of the study is the proportion of subjects with HIV-1 RNA < 50 copies/mL (Intent-to-treat) at Week 48 with a non-inferiority analysis.
Secondary Measures:
♦ In the PROGRESS study, Abbott will evaluate:
♦ Metabolic effects, including a lipid profile, fat distribution and insulin resistance; and
♦ Safety of Kaletra and Isentress used in combination;
♦ Viral dynamics;
♦ Efficacy and antiviral resistance between the regimens; ♦ Adherence;
♦ Patient-reported outcomes.
♦ PROGRESS is a global, multicenter study of approximately 200 patients. The study is fully enrolled and results are expected in the second half of 2009.
♦ The PROGRESS study is an opportunity for Abbott to explore Kaletra for use in combination with new classes of antiretroviral agents.
♦ Kaletra has been studied for seven years, which is the longest running study of any PI
♦ Kaletra is the only co-formulated protease inhibitor that can be taken once-daily in nieve adult patients in the U.S. Once-daily is not approved in all countries outside the U.S.
♦ Isentress is an integrase inhibitor, a new class of HIV treatment.
♦ Isentress is approved for use (in the United States and in Europe) in antiretroviral-experienced patients.
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