At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Genetic Predictors of Pharmacokinetic Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin: the Role of SLCO1B1 Polymorphisms.
In Brief
A Phase 4 clinical trial evaluating Pravastatin, Darunavir, and 2 other interventions for HIV Infections and Hyperlipidemia. Completed, enrolled 32 participants across 1 site.
Detailed Summary
Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.
Study Details
Timeline
Interventions
Pravastatin 40 mg by mouth daily on days 1-4
Darunavir 600mg by mouth twice daily on days 12-18
Ritonavir 100mg by mouth twice daily on days 12-18
Pravastatin 40 mg by mouth daily on days 15-18
Washout (no medication) on days 5-11.