Potent

Abstract: 13691 A40 - Protease inhibitors

25 A40

POTENT: a randomised, prospective trial comparing the efficacy and safety of tipranavir/ritonavir (TPV/r) and darunavir/ritonavir (DRV/r) D.W. Cameron 3. University of Ottawa at The Ottawa Hospital, Canada`, Infectious Diseases, Ottawa, Canada Abstract The efficacy and safety of TPV/r (500/200 mg BID) in antiretroviral-experienced patients have been demonstrated in the large scale, Phase III RESIST studies (n=746). DRV/r was studied in the Phase II POWER dose finding studies (600/100 mg BID: n=131). Cross-trial comparisons between RESIST and POWER are not possible due to differences in patient and disease related baseline characteristics, number of subjects, use of other active drugs (enfuvirtide), calendar years and duration of study, and analytical methodologies. POTENT is a recently initiated, Boehringer Ingelheim-sponsored prospective, randomized, direct comparison of TPV/r and DRV/r in ARV-experienced patients with at least partial susceptibility to both PIs. Methods: The efficacy and safety of TPV/r (500/200mg BID) and DRV/r (600/100 mg BID) plus optimised background regimens (OBR) will be compared for one year in triple class experienced patients with resistance to >1 PI and at least partial susceptibility to both TPV and DRV by virtual phenotype resistance testing. The OBR will contain >2 active NRTIs; or active NRTI(s) plus enfuvirtide or raltegravir or maraviroc (if patient is naïve to these agents); or 0 or 1 active NRTI plus 2 of enfuvirtide, raltegravir or maraviroc. Treatment response (VL <50 copies/mL) at Week 48; time to loss of virologic response or virological failure (>400 and >50 copies/mL); treatment status and virological response at each study visit; and immunological responses will be determined. Results: 800 patients will be randomized 1:1 to TPV/r or DRV/r. Results are anticipated in late 2009. Conclusions: Results from POTENT will enable physicians to better define differences in efficacy and tolerability between TPV/r and DRV/r, as well as identifying which patients will derive the most virological and immunological benefit from each drug. The study will also provide data regarding the efficacy and safety of TPV/r and DRV/r used with new antiretrovirals from novel drug classes. TOP300_A Country(ies) of Research: Argentina, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Mexico, Portugal, Spain, Switzerland, Thailand, United States Presenter: Mr. Professor D. William Cameron, 3. University of Ottawa at The Ottawa Hospital, Canada`, Ottawa [Canada]