NCT00630734

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

Genetic Predictors of Pharmacokinetic Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin: the Role of SLCO1B1 Polymorphisms.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Pravastatin	Pravastatin 40 mg by mouth daily on days 1-4
DRUG	Darunavir	Darunavir 600mg by mouth twice daily on days 12-18
DRUG	Ritonavir	Ritonavir 100mg by mouth twice daily on days 12-18
DRUG	Pravastatin	Pravastatin 40 mg by mouth daily on days 15-18
OTHER	Washout	Washout (no medication) on days 5-11.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-10-01
• Completion: 2010-09-01
• First posted: 2008-03-07
• Last updated: 2014-05-22
• Results posted: 2012-11-15

Locations

1 site across 1 country: United States