Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

Exclusion Criteria

• •Currently active or chronic cardiovascular, hepatic, renal, pancreatic, gastrointestinal, neurologic, hematologic, psychiatric, metabolic, respiratory, inflammatory, or infectious disease
• •Chronic pancreatitis
• •History of rhabdomyolysis
• •History of statin-associated myopathy
• •Active malignancy
• •History of significant skin disease, food allergy, drug allergy, dermatitis, eczema, psoriasis
• •Pregnancy/breastfeeding
• •HIV positive and/or AIDS
• •serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range \[ULN\]);
• •hemoglobin grade 1 or greater (≤ 10.9 g/dL);
• •platelet count grade 1 or greater (≤ 124.999 x 109/L);
• •absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L);
• •aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN);
• •total bilirubin grade 1 or greater (≥ 1.1 x ULN)
• •serum lipase grade 1 or greater (≥ 1.1 x ULN)
• •serum amylase grade 1 or greater (≥ 1.1 x ULN)
• •any other laboratory abnormality of grade 2 or above