BACKGROUND: BI 1182.2, an open-label, randomized, multicenter, phase 2 study, evaluated efficacy and tolerability of the protease inhibitor (PI) tipranavir (TPV; 500 mg twice daily or 1000 mg twice daily) administered with ritonavir (100 mg twice daily) in combination with 1 nucleoside reverse transcriptase inhibitor and 1 nonnucleoside reverse transcriptase inhibitor in multiple PI-experienced HIV-1-infected patients. METHODS:Forty-one patients were evaluated in 2 arms: low-dose (19 patients) or high-dose (22 patients) ritonavir-boosted tipranavir (TPV/r). Primary endpoints were change from baseline in HIV-1 RNA concentrations at weeks 16, 24, 48, and 80 and percentage of patients with plasma HIV-1 RNA levels lower than the limit of quantitation. Safety was evaluated by adverse events (AEs), grade 3/4 abnormalities, and serious AEs. RESULTS: Of all patients, 59% were still receiving TPV/r (14 in low-dose arm and 10 in high-dose arm) at week 80. Patients in both arms had a median >2.0-log10 reduction in plasma viral load. Intent-to-treat analysis demonstrated that a similar proportion of patients in the high-dose and low-dose groups achieved plasma HIV-1 RNA levels <50 copies/mL at week 80 (43% vs. 32%; P = 0.527). The most frequently observed AEs were diarrhea, headache, and nausea. CONCLUSION: TPV/r combined with other active antiretroviral agents can provide a durable treatment response for highly treatment-experienced patients.
RCT Entities:
BACKGROUND: BI 1182.2, an open-label, randomized, multicenter, phase 2 study, evaluated efficacy and tolerability of the protease inhibitor (PI) tipranavir (TPV; 500 mg twice daily or 1000 mg twice daily) administered with ritonavir (100 mg twice daily) in combination with 1 nucleoside reverse transcriptase inhibitor and 1 nonnucleoside reverse transcriptase inhibitor in multiple PI-experienced HIV-1-infectedpatients. METHODS: Forty-one patients were evaluated in 2 arms: low-dose (19 patients) or high-dose (22 patients) ritonavir-boosted tipranavir (TPV/r). Primary endpoints were change from baseline in HIV-1 RNA concentrations at weeks 16, 24, 48, and 80 and percentage of patients with plasma HIV-1 RNA levels lower than the limit of quantitation. Safety was evaluated by adverse events (AEs), grade 3/4 abnormalities, and serious AEs. RESULTS: Of all patients, 59% were still receiving TPV/r (14 in low-dose arm and 10 in high-dose arm) at week 80. Patients in both arms had a median >2.0-log10 reduction in plasma viral load. Intent-to-treat analysis demonstrated that a similar proportion of patients in the high-dose and low-dose groups achieved plasma HIV-1 RNA levels <50 copies/mL at week 80 (43% vs. 32%; P = 0.527). The most frequently observed AEs were diarrhea, headache, and nausea. CONCLUSION:TPV/r combined with other active antiretroviral agents can provide a durable treatment response for highly treatment-experienced patients.
Authors: Ahmed M Bayoumi; Paul G Barnett; Vilija R Joyce; Susan C Griffin; Huiying Sun; Nick J Bansback; Mark Holodniy; Gillian Sanders; Sheldon T Brown; Tassos C Kyriakides; Brian Angus; D William Cameron; Aslam H Anis; Mark Sculpher; Douglas K Owens Journal: J Acquir Immune Defic Syndr Date: 2013-12-01 Impact factor: 3.731
Authors: Usman Arshad; Henry Pertinez; Helen Box; Lee Tatham; Rajith K R Rajoli; Paul Curley; Megan Neary; Joanne Sharp; Neill J Liptrott; Anthony Valentijn; Christopher David; Steve P Rannard; Paul M O'Neill; Ghaith Aljayyoussi; Shaun H Pennington; Stephen A Ward; Andrew Hill; David J Back; Saye H Khoo; Patrick G Bray; Giancarlo A Biagini; Andrew Owen Journal: Clin Pharmacol Ther Date: 2020-06-14 Impact factor: 6.903