OBJECTIVE: To investigate the efficacy and safety of high-dose lopinavir/ritonavir (LPV/r) therapy in multiple protease inhibitor, non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced subjects. METHOD: Thirty-sixHIV-1-infected subjects were randomized to LPV/r 400/300 mg or 667/167 mg bid in a 48-week, open-label study. Subjects also received investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). Primary outcomes were the proportion of subjects with HIV-1 RNA levels <50 copies/mL at week 24 and time until loss of virologic response through week 48. RESULTS: Six of 17 (35%) and 10 of 19 (53%) subjects in the 400/300 and 667/167 groups, respectively, completed 48 weeks of treatment. Median durations of follow-up in discontinued subjects and all subjects were 15 weeks and 32 weeks, respectively. Forty-four percent of subjects achieved HIV-1 RNA <50 copies/mL at least once; 18% (400/300 mg) and 21% (667/167 mg) of subjects achieved HIV-1 RNA <50 copies/mL at week 24 (intent-to-treat analysis). Corresponding results at week 48 were 18% (400/300 mg) and 26% (667/167 mg). No statistically significant differences in adverse event incidence occurred between treatment groups, except for a higher vomiting rate in the 400/300 mg dose group. Predictors of response included baseline LPV inhibitory quotient and number of active NRTIs. CONCLUSION: Higher doses of LPV/r may provide substantial antiviral activity in multiple class-experienced subjects.
RCT Entities:
OBJECTIVE: To investigate the efficacy and safety of high-dose lopinavir/ritonavir (LPV/r) therapy in multiple protease inhibitor, non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced subjects. METHOD: Thirty-six HIV-1-infected subjects were randomized to LPV/r 400/300 mg or 667/167 mg bid in a 48-week, open-label study. Subjects also received investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). Primary outcomes were the proportion of subjects with HIV-1 RNA levels <50 copies/mL at week 24 and time until loss of virologic response through week 48. RESULTS: Six of 17 (35%) and 10 of 19 (53%) subjects in the 400/300 and 667/167 groups, respectively, completed 48 weeks of treatment. Median durations of follow-up in discontinued subjects and all subjects were 15 weeks and 32 weeks, respectively. Forty-four percent of subjects achieved HIV-1 RNA <50 copies/mL at least once; 18% (400/300 mg) and 21% (667/167 mg) of subjects achieved HIV-1 RNA <50 copies/mL at week 24 (intent-to-treat analysis). Corresponding results at week 48 were 18% (400/300 mg) and 26% (667/167 mg). No statistically significant differences in adverse event incidence occurred between treatment groups, except for a higher vomiting rate in the 400/300 mg dose group. Predictors of response included baseline LPV inhibitory quotient and number of active NRTIs. CONCLUSION: Higher doses of LPV/r may provide substantial antiviral activity in multiple class-experienced subjects.
Authors: Roberta Prinapori; Raffaella Rosso; Antonio Di Biagio; Franca Miletich; Elisa Furfaro; Lucia Taramasso; Francesca Ginocchio; Vania Giacomet; Loredana Nulvesu; Maria Pia Sormani; Irene Schiavetti; Alessio Signori; Laura De Hoffer; Claudio Viscoli Journal: Indian J Pediatr Date: 2013-09-07 Impact factor: 1.967
Authors: Brian L Robbins; Edmund V Capparelli; Ellen G Chadwick; Ram Yogev; Leslie Serchuck; Carol Worrell; Mary Elizabeth Smith; Carmelita Alvero; Terence Fenton; Barbara Heckman; Stephen I Pelton; Grace Aldrovandi; William Borkowsky; John Rodman; Peter L Havens Journal: Antimicrob Agents Chemother Date: 2008-07-14 Impact factor: 5.191
Authors: Natella Rakhmanina; John van den Anker; Aline Baghdassarian; Steven Soldin; Keetra Williams; Michael N Neely Journal: Antimicrob Agents Chemother Date: 2009-03-02 Impact factor: 5.191