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This was a randomized, open-label, 2-period, 2-sequence crossover study conducted in healthy adults. All participants received dolutegravir (DTG) 30mg QD for 5 days in the first treatment period. In the second treatment period, participants then received DTG 30mg QD plus either lopinavir/ritonavir (LPV/r) 400/100mg Q 12h, or darunavir/ritonavir (DRV/r) 600/100mg Q 12h for 14 days, with no washout period in between. All doses were administered within 30 minutes of a moderately fatty meal. Blood samples for pharmacokinetic (PK) analysis were obtained on the last day of each treatment period.
The geometric mean ratio (90% confidence interval) for the AUC, Cmax, and Cmin were 0.97 (90%CI 0.91-1.04), 1.00 (90%CI 0.94-1.07) and 1.02 (90%CI 0.88-1.17) respectively. No dose adjustment is necessary.
Co-administration of DTG + LPV/r had no effect on the steady state DTG PK when compared to DTG alone.
Song I, Borland J, Min SS. The effect of lopinavir/ritonavir and darunavir/ritonavir on the hiv integrase inhibitor s/gsk1349572 in healthy participants. Journal Of Clinical Pharmacology. 2011; 2: 237-242.